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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121453145 | 12145314 | 5 | F | 201510 | 20160705 | 20160304 | 20160711 | EXP | PHHY2016CO028587 | NOVARTIS | 56.14 | YR | M | Y | 51.00000 | KG | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121453145 | 12145314 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 800 MG, QD | Y | S00208 | 22068 | 800 | MG | CAPSULE | QD | ||||
| 121453145 | 12145314 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID (IN THE MORNING AND IN THE AFTERNOON) | Y | 22068 | 300 | MG | CAPSULE | BID | |||||
| 121453145 | 12145314 | 3 | SS | NILOTINIB | NILOTINIB | 1 | Unknown | U | 22068 | ||||||||||
| 121453145 | 12145314 | 4 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 1 DF, QD (MORNING) | U | 0 | 1 | DF | TABLET | QD | |||||
| 121453145 | 12145314 | 5 | C | CEPHALEXIN. | CEPHALEXIN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121453145 | 12145314 | 1 | Chronic myeloid leukaemia |
| 121453145 | 12145314 | 3 | Product used for unknown indication |
| 121453145 | 12145314 | 4 | Product used for unknown indication |
| 121453145 | 12145314 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121453145 | 12145314 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121453145 | 12145314 | Abdominal pain | |
| 121453145 | 12145314 | Cholelithiasis | |
| 121453145 | 12145314 | Gallbladder obstruction | |
| 121453145 | 12145314 | Hypersensitivity | |
| 121453145 | 12145314 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |