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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115857236 | 11585723 | 6 | F | 201409 | 20160819 | 20151001 | 20160824 | EXP | PHHY2015CR117092 | NOVARTIS | 18.60 | YR | F | Y | 63.00000 | KG | 20160824 | CN | COUNTRY NOT SPECIFIED | CR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115857236 | 11585723 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 200 MG, BID | 22068 | 200 | MG | CAPSULE | BID | ||||||
| 115857236 | 11585723 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 200 MG, BID | 22068 | 200 | MG | CAPSULE | BID | ||||||
| 115857236 | 11585723 | 3 | C | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 54 MG, QD | Y | 0 | 54 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115857236 | 11585723 | 1 | Chronic myeloid leukaemia |
| 115857236 | 11585723 | 3 | Disturbance in attention |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115857236 | 11585723 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115857236 | 11585723 | Blast cell count increased | |
| 115857236 | 11585723 | Dry skin | |
| 115857236 | 11585723 | Maternal exposure during pregnancy | |
| 115857236 | 11585723 | Platelet count increased | |
| 115857236 | 11585723 | Polyhydramnios | |
| 115857236 | 11585723 | Premature delivery | |
| 115857236 | 11585723 | Pruritus | |
| 115857236 | 11585723 | Rash papular | |
| 115857236 | 11585723 | Therapy non-responder | |
| 115857236 | 11585723 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 115857236 | 11585723 | 1 | 201409 | 201502 | 0 | |
| 115857236 | 11585723 | 2 | 201505 | 0 | ||
| 115857236 | 11585723 | 3 | 2011 | 201501 | 0 |