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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 920165413 | 9201654 | 13 | F | 201203 | 20160718 | 20130401 | 20160722 | EXP | PHHY2012CA116951 | NOVARTIS | 34.75 | YR | M | Y | 0.00000 | 20160722 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 920165413 | 9201654 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 400 MG, BID | N | 22068 | 400 | MG | CAPSULE | BID | |||||
| 920165413 | 9201654 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | N | 22068 | 300 | MG | CAPSULE | BID | |||||
| 920165413 | 9201654 | 3 | SS | TASIGNA | NILOTINIB | 1 | Oral | 450 MG, QD (300 MG IN MORNING AND 150 MG IN EVENING) | N | 22068 | 450 | MG | CAPSULE | QD | |||||
| 920165413 | 9201654 | 4 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, QD | N | 22068 | 300 | MG | CAPSULE | QD | |||||
| 920165413 | 9201654 | 5 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 920165413 | 9201654 | 1 | Chronic myeloid leukaemia |
| 920165413 | 9201654 | 5 | Blood cholesterol increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 920165413 | 9201654 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 920165413 | 9201654 | Acne | |
| 920165413 | 9201654 | Blood cholesterol abnormal | |
| 920165413 | 9201654 | Blood pressure abnormal | |
| 920165413 | 9201654 | Blood pressure increased | |
| 920165413 | 9201654 | Bronchitis | |
| 920165413 | 9201654 | Chills | |
| 920165413 | 9201654 | Cold sweat | |
| 920165413 | 9201654 | Cough | |
| 920165413 | 9201654 | Dry skin | |
| 920165413 | 9201654 | Ear infection | |
| 920165413 | 9201654 | Ear pain | |
| 920165413 | 9201654 | Eczema | |
| 920165413 | 9201654 | Eyelid skin dryness | |
| 920165413 | 9201654 | Fatigue | |
| 920165413 | 9201654 | Headache | |
| 920165413 | 9201654 | Inappropriate schedule of drug administration | |
| 920165413 | 9201654 | Nasal congestion | |
| 920165413 | 9201654 | Nasopharyngitis | |
| 920165413 | 9201654 | Neck pain | |
| 920165413 | 9201654 | Platelet count decreased | |
| 920165413 | 9201654 | Productive cough | |
| 920165413 | 9201654 | Pyrexia | |
| 920165413 | 9201654 | Rhinorrhoea | |
| 920165413 | 9201654 | Skin disorder | |
| 920165413 | 9201654 | Tympanic membrane perforation | |
| 920165413 | 9201654 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 920165413 | 9201654 | 1 | 20120301 | 0 | ||
| 920165413 | 9201654 | 2 | 201203 | 0 |