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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 954742019 | 9547420 | 19 | F | 20111014 | 20160811 | 20130924 | 20160818 | EXP | PHHY2013IL026062 | NOVARTIS | 64.00 | YR | F | Y | 91.00000 | KG | 20160818 | OT | IL | IL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 954742019 | 9547420 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 400 MG, BID | U | 22068 | 400 | MG | CAPSULE | BID | |||||
| 954742019 | 9547420 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | U | 22068 | 300 | MG | CAPSULE | BID | |||||
| 954742019 | 9547420 | 3 | SS | TASIGNA | NILOTINIB | 1 | Oral | UNK | U | 22068 | CAPSULE | ||||||||
| 954742019 | 9547420 | 4 | SS | TASIGNA | NILOTINIB | 1 | Oral | 200 MG, BID | U | 22068 | 200 | MG | CAPSULE | BID | |||||
| 954742019 | 9547420 | 5 | SS | TASIGNA | NILOTINIB | 1 | Unknown | 800 MG, UNK | U | 22068 | 800 | MG | CAPSULE | ||||||
| 954742019 | 9547420 | 6 | SS | TASIGNA | NILOTINIB | 1 | Oral | 600 MG, QD (400 MG IN THE MORNING AND 200 MG IN THE EVENING) | U | SO102 | 22068 | 600 | MG | CAPSULE | QD | ||||
| 954742019 | 9547420 | 7 | SS | TASIGNA | NILOTINIB | 1 | Oral | 300 MG, BID | U | SO076 | 22068 | 300 | MG | CAPSULE | BID | ||||
| 954742019 | 9547420 | 8 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 954742019 | 9547420 | 1 | Chronic myeloid leukaemia |
| 954742019 | 9547420 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 954742019 | 9547420 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 954742019 | 9547420 | Abdominal discomfort | |
| 954742019 | 9547420 | Abdominal distension | |
| 954742019 | 9547420 | Abdominal pain | |
| 954742019 | 9547420 | Abdominal pain upper | |
| 954742019 | 9547420 | Acne | |
| 954742019 | 9547420 | Anaemia | |
| 954742019 | 9547420 | Asthenia | |
| 954742019 | 9547420 | Blood glucose decreased | |
| 954742019 | 9547420 | Blood glucose increased | |
| 954742019 | 9547420 | Blood pressure decreased | |
| 954742019 | 9547420 | Blood uric acid increased | |
| 954742019 | 9547420 | Burning sensation | |
| 954742019 | 9547420 | Chest pain | |
| 954742019 | 9547420 | Cough | |
| 954742019 | 9547420 | Decreased appetite | |
| 954742019 | 9547420 | Diarrhoea | |
| 954742019 | 9547420 | Discomfort | |
| 954742019 | 9547420 | Dizziness | |
| 954742019 | 9547420 | Drug intolerance | |
| 954742019 | 9547420 | Dry eye | |
| 954742019 | 9547420 | Dry skin | |
| 954742019 | 9547420 | Dysgeusia | |
| 954742019 | 9547420 | Ear infection | |
| 954742019 | 9547420 | Ear pain | |
| 954742019 | 9547420 | Eructation | |
| 954742019 | 9547420 | Fat tissue increased | |
| 954742019 | 9547420 | Fatigue | |
| 954742019 | 9547420 | Feeling abnormal | |
| 954742019 | 9547420 | Feeling cold | |
| 954742019 | 9547420 | Feeling hot | |
| 954742019 | 9547420 | Flushing | |
| 954742019 | 9547420 | Gastritis | |
| 954742019 | 9547420 | Gastritis erosive | |
| 954742019 | 9547420 | Glycosylated haemoglobin decreased | |
| 954742019 | 9547420 | Hair texture abnormal | |
| 954742019 | 9547420 | Hernia | |
| 954742019 | 9547420 | Hyperhidrosis | |
| 954742019 | 9547420 | Lipoma | |
| 954742019 | 9547420 | Malaise | |
| 954742019 | 9547420 | Nasopharyngitis | |
| 954742019 | 9547420 | Nausea | |
| 954742019 | 9547420 | Nightmare | |
| 954742019 | 9547420 | Pain | |
| 954742019 | 9547420 | Productive cough | |
| 954742019 | 9547420 | Pruritus | |
| 954742019 | 9547420 | Pyrexia | |
| 954742019 | 9547420 | Skin lesion | |
| 954742019 | 9547420 | Skin wrinkling | |
| 954742019 | 9547420 | Sleep disorder | |
| 954742019 | 9547420 | Thirst decreased | |
| 954742019 | 9547420 | Urinary tract infection | |
| 954742019 | 9547420 | Viral infection | |
| 954742019 | 9547420 | Visual acuity reduced | |
| 954742019 | 9547420 | Vulvovaginal mycotic infection |
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 |
|---|---|---|---|---|---|---|
| 954742019 | 9547420 | 1 | 2011 | 0 | ||
| 954742019 | 9547420 | 2 | 20111101 | 0 | ||
| 954742019 | 9547420 | 3 | 20111116 | 0 | ||
| 954742019 | 9547420 | 4 | 2012 | 0 | ||
| 954742019 | 9547420 | 7 | 201412 | 0 |