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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125545811 | 12554581 | 1 | I | 20150527 | 20160704 | 20160713 | 20160713 | EXP | PHHY2016PT094724 | NOVARTIS | 32.42 | YR | M | Y | 65.00000 | KG | 20160713 | MD | PT | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125545811 | 12554581 | 1 | PS | TASIGNA | NILOTINIB | 1 | Unknown | 600 MG, QD | U | 22068 | 600 | MG | CAPSULE | QD | |||||
| 125545811 | 12554581 | 2 | C | HIDROXIUREA | HYDROXYUREA | 1 | 1 G, TID | Y | 0 | 1 | G | TID | |||||||
| 125545811 | 12554581 | 3 | C | ACIDO FOLICO /01079901/ | 2 | Unknown | 5 MG, QD | 0 | 5 | MG | QD | ||||||||
| 125545811 | 12554581 | 4 | C | OMEPRAZOL | OMEPRAZOLE | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 125545811 | 12554581 | 5 | C | TRAMADOL + PARACETAMOL | ACETAMINOPHENTRAMADOL | 1 | Unknown | 37.5 + 325 MG, SOS | Y | 0 | |||||||||
| 125545811 | 12554581 | 6 | C | METOCLOPRAMIDA | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Unknown | 10 MG, SOS | Y | 0 | 10 | MG | |||||||
| 125545811 | 12554581 | 7 | C | ARA-C | CYTARABINE | 1 | Unknown | 300 MG, QD | 300 | MG | Y | 0 | 300 | MG | QD | ||||
| 125545811 | 12554581 | 8 | C | RASBURICASE | RASBURICASE | 1 | Unknown | 15 MG, QD | 15 | MG | Y | 0 | 15 | MG | QD | ||||
| 125545811 | 12554581 | 9 | C | BICARBONATO | 2 | Unknown | 500 ML, QD | 500 | ML | Y | 0 | 500 | ML | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125545811 | 12554581 | 1 | Chronic myeloid leukaemia |
| 125545811 | 12554581 | 2 | Product used for unknown indication |
| 125545811 | 12554581 | 3 | Product used for unknown indication |
| 125545811 | 12554581 | 4 | Product used for unknown indication |
| 125545811 | 12554581 | 5 | Analgesic therapy |
| 125545811 | 12554581 | 6 | Nausea |
| 125545811 | 12554581 | 7 | Product used for unknown indication |
| 125545811 | 12554581 | 8 | Product used for unknown indication |
| 125545811 | 12554581 | 9 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125545811 | 12554581 | Abdominal pain | |
| 125545811 | 12554581 | Abdominal pain upper | |
| 125545811 | 12554581 | Pruritus |
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 |
|---|---|---|---|---|---|---|
| 125545811 | 12554581 | 1 | 20141126 | 0 | ||
| 125545811 | 12554581 | 2 | 20141108 | 0 | ||
| 125545811 | 12554581 | 3 | 20131109 | 0 | ||
| 125545811 | 12554581 | 4 | 20141108 | 0 | ||
| 125545811 | 12554581 | 5 | 20141108 | 0 | ||
| 125545811 | 12554581 | 6 | 20141108 | 0 | ||
| 125545811 | 12554581 | 7 | 20141108 | 20141108 | 0 | |
| 125545811 | 12554581 | 8 | 20141108 | 20141108 | 0 | |
| 125545811 | 12554581 | 9 | 20141108 | 20141108 | 0 |