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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1048930919 | 10489309 | 19 | F | 2008 | 20160921 | 20141002 | 20160927 | EXP | PHHY2014IL105508 | NOVARTIS | 53.00 | YR | M | Y | 64.00000 | KG | 20160927 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1048930919 | 10489309 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 400 MG, BID | S0086 | 22068 | 400 | MG | CAPSULE | BID | |||||
| 1048930919 | 10489309 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 400 MG, BID | S0086 | 22068 | 400 | MG | CAPSULE | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1048930919 | 10489309 | 1 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1048930919 | 10489309 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1048930919 | 10489309 | Anaemia | |
| 1048930919 | 10489309 | Arthralgia | |
| 1048930919 | 10489309 | Blood urine present | |
| 1048930919 | 10489309 | Burning sensation | |
| 1048930919 | 10489309 | Decreased appetite | |
| 1048930919 | 10489309 | Depressed mood | |
| 1048930919 | 10489309 | Depression | |
| 1048930919 | 10489309 | Dizziness | |
| 1048930919 | 10489309 | Dyspepsia | |
| 1048930919 | 10489309 | Dysuria | |
| 1048930919 | 10489309 | Eating disorder | |
| 1048930919 | 10489309 | Erectile dysfunction | |
| 1048930919 | 10489309 | Gastritis | |
| 1048930919 | 10489309 | Glossodynia | |
| 1048930919 | 10489309 | Haematemesis | |
| 1048930919 | 10489309 | Haematochezia | |
| 1048930919 | 10489309 | Haemorrhoidal haemorrhage | |
| 1048930919 | 10489309 | Hyperchlorhydria | |
| 1048930919 | 10489309 | Iron deficiency | |
| 1048930919 | 10489309 | Low density lipoprotein increased | |
| 1048930919 | 10489309 | Mental disorder | |
| 1048930919 | 10489309 | Mood altered | |
| 1048930919 | 10489309 | Nervousness | |
| 1048930919 | 10489309 | Pyrexia | |
| 1048930919 | 10489309 | Rectal haemorrhage | |
| 1048930919 | 10489309 | Sleep disorder | |
| 1048930919 | 10489309 | Stomatitis | |
| 1048930919 | 10489309 | Tongue discolouration | |
| 1048930919 | 10489309 | Tooth disorder | |
| 1048930919 | 10489309 | Urinary tract infection | |
| 1048930919 | 10489309 | 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 |
|---|---|---|---|---|---|---|
| 1048930919 | 10489309 | 1 | 20080804 | 20160821 | 0 | |
| 1048930919 | 10489309 | 2 | 201608 | 0 |