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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106186678 | 10618667 | 8 | F | 20160829 | 20141202 | 20160901 | EXP | PHHY2013CA065916 | NOVARTIS | 0.00 | M | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106186678 | 10618667 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | Y | 22068 | 300 | MG | CAPSULE | BID | |||||
| 106186678 | 10618667 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | Y | 22068 | 300 | MG | CAPSULE | BID | |||||
| 106186678 | 10618667 | 3 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, QD (ALL AT ONCE IN THE MORNING) | Y | 22068 | 300 | MG | CAPSULE | QD | |||||
| 106186678 | 10618667 | 4 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | Y | 22068 | 300 | MG | CAPSULE | BID | |||||
| 106186678 | 10618667 | 5 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, QD | Y | 22068 | 300 | MG | CAPSULE | QD | |||||
| 106186678 | 10618667 | 6 | C | ALEVE | NAPROXEN SODIUM | 1 | Unknown | UNK UNK, PRN | U | 0 | |||||||||
| 106186678 | 10618667 | 7 | C | ASA | ASPIRIN | 1 | Unknown | 81 MG, QD | U | 0 | 81 | MG | QD | ||||||
| 106186678 | 10618667 | 8 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | UNK UNK, PRN | U | 0 | |||||||||
| 106186678 | 10618667 | 9 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Unknown | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106186678 | 10618667 | 1 | Chronic myeloid leukaemia |
| 106186678 | 10618667 | 6 | Headache |
| 106186678 | 10618667 | 7 | Product used for unknown indication |
| 106186678 | 10618667 | 8 | Headache |
| 106186678 | 10618667 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 106186678 | 10618667 | OT |
| 106186678 | 10618667 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106186678 | 10618667 | Abnormal dreams | |
| 106186678 | 10618667 | Aortic dilatation | |
| 106186678 | 10618667 | Back pain | |
| 106186678 | 10618667 | Blood cholesterol increased | |
| 106186678 | 10618667 | Blood pressure increased | |
| 106186678 | 10618667 | Chest pain | |
| 106186678 | 10618667 | Concomitant disease aggravated | |
| 106186678 | 10618667 | Cough | |
| 106186678 | 10618667 | Decreased appetite | |
| 106186678 | 10618667 | Dizziness | |
| 106186678 | 10618667 | Dysgeusia | |
| 106186678 | 10618667 | Dyspnoea | |
| 106186678 | 10618667 | Fatigue | |
| 106186678 | 10618667 | Feeling abnormal | |
| 106186678 | 10618667 | Gastrointestinal oedema | |
| 106186678 | 10618667 | Hair growth abnormal | |
| 106186678 | 10618667 | Headache | |
| 106186678 | 10618667 | Hypoaesthesia | |
| 106186678 | 10618667 | Hypotonia | |
| 106186678 | 10618667 | Miliaria | |
| 106186678 | 10618667 | Nasopharyngitis | |
| 106186678 | 10618667 | Neck pain | |
| 106186678 | 10618667 | Night sweats | |
| 106186678 | 10618667 | Overweight | |
| 106186678 | 10618667 | Photosensitivity reaction | |
| 106186678 | 10618667 | Pigmentation disorder | |
| 106186678 | 10618667 | Pleurisy | |
| 106186678 | 10618667 | Pruritus | |
| 106186678 | 10618667 | Pyrexia | |
| 106186678 | 10618667 | Rash | |
| 106186678 | 10618667 | Rhinorrhoea | |
| 106186678 | 10618667 | Sleep disorder | |
| 106186678 | 10618667 | Sneezing | |
| 106186678 | 10618667 | Solar lentigo | |
| 106186678 | 10618667 | Therapeutic response unexpected | |
| 106186678 | 10618667 | Throat irritation | |
| 106186678 | 10618667 | Weight decreased | |
| 106186678 | 10618667 | White blood cell count 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 |
|---|---|---|---|---|---|---|
| 106186678 | 10618667 | 1 | 20130506 | 0 | ||
| 106186678 | 10618667 | 2 | 20130615 | 0 | ||
| 106186678 | 10618667 | 9 | 20151005 | 0 |