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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125874552 | 12587455 | 2 | F | 20151015 | 20160802 | 20160725 | 20160809 | EXP | PHHY2015CO159067 | NOVARTIS | 72.57 | YR | M | Y | 97.00000 | KG | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125874552 | 12587455 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 150 MG, QID | 22068 | 150 | MG | CAPSULE | QID | ||||||
| 125874552 | 12587455 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 150 MG, QID | 22068 | 150 | MG | CAPSULE | QID | ||||||
| 125874552 | 12587455 | 3 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | ONCE DAILY | U | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125874552 | 12587455 | 1 | Chronic myeloid leukaemia |
| 125874552 | 12587455 | 3 | Gastrointestinal disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125874552 | 12587455 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125874552 | 12587455 | Abdominal pain | |
| 125874552 | 12587455 | Alcohol poisoning | |
| 125874552 | 12587455 | Cholelithiasis | |
| 125874552 | 12587455 | Condition aggravated | |
| 125874552 | 12587455 | Drug intolerance | |
| 125874552 | 12587455 | Eye pain | |
| 125874552 | 12587455 | Haematemesis | |
| 125874552 | 12587455 | Headache | |
| 125874552 | 12587455 | Incorrect drug administration duration | |
| 125874552 | 12587455 | Loss of consciousness | |
| 125874552 | 12587455 | Malaise | |
| 125874552 | 12587455 | Mouth haemorrhage | |
| 125874552 | 12587455 | Pain | |
| 125874552 | 12587455 | Pain in extremity | |
| 125874552 | 12587455 | Peripheral swelling | |
| 125874552 | 12587455 | Pyrexia | |
| 125874552 | 12587455 | Splenomegaly | |
| 125874552 | 12587455 | 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 |
|---|---|---|---|---|---|---|
| 125874552 | 12587455 | 1 | 20130530 | 201601 | 0 | |
| 125874552 | 12587455 | 2 | 20160617 | 0 |