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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125096246 | 12509624 | 6 | F | 20160725 | 20160629 | 20160729 | EXP | PHHY2016CO057491 | NOVARTIS | 0.00 | F | Y | 50.00000 | KG | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125096246 | 12509624 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 200 MG, BID | 22068 | 200 | MG | CAPSULE | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125096246 | 12509624 | 1 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125096246 | 12509624 | HO |
| 125096246 | 12509624 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125096246 | 12509624 | Cervix carcinoma | |
| 125096246 | 12509624 | Chest pain | |
| 125096246 | 12509624 | Chills | |
| 125096246 | 12509624 | Chronic myeloid leukaemia | |
| 125096246 | 12509624 | Chronic myeloid leukaemia recurrent | |
| 125096246 | 12509624 | General physical health deterioration | |
| 125096246 | 12509624 | Haematemesis | |
| 125096246 | 12509624 | Immunodeficiency | |
| 125096246 | 12509624 | Malignant neoplasm progression | |
| 125096246 | 12509624 | Pain in extremity | |
| 125096246 | 12509624 | Papilloma viral infection | |
| 125096246 | 12509624 | Pneumonia | |
| 125096246 | 12509624 | Pyrexia | |
| 125096246 | 12509624 | Second primary malignancy |
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 |
|---|---|---|---|---|---|---|
| 125096246 | 12509624 | 1 | 20150311 | 0 |