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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119720609 | 11972060 | 9 | F | 20160122 | 20160829 | 20160128 | 20160906 | EXP | PHHY2016LB008493 | NOVARTIS | 36.28 | YR | F | Y | 0.00000 | 20160906 | MD | LB | LB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119720609 | 11972060 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 600 MG, QD | U | 22068 | 600 | MG | CAPSULE | QD | |||||
| 119720609 | 11972060 | 2 | C | EUTHYROX | LEVOTHYROXINE SODIUM | 1 | Oral | 100 UG, QD | 0 | 100 | UG | QD | |||||||
| 119720609 | 11972060 | 3 | C | EUTHYROX | LEVOTHYROXINE SODIUM | 1 | Oral | 150 UG, QD | 0 | 150 | UG | QD | |||||||
| 119720609 | 11972060 | 4 | C | ZYLORIC | ALLOPURINOL | 1 | Oral | 300 MG, FOR 10 DAYS PER MONTH | U | 0 | 300 | MG | |||||||
| 119720609 | 11972060 | 5 | C | EURO D | 2 | Oral | 1 DF, EVERY 3 DAYS | U | 0 | 1 | DF | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119720609 | 11972060 | 1 | Chronic myeloid leukaemia |
| 119720609 | 11972060 | 2 | Product used for unknown indication |
| 119720609 | 11972060 | 4 | Product used for unknown indication |
| 119720609 | 11972060 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119720609 | 11972060 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119720609 | 11972060 | Abdominal distension | |
| 119720609 | 11972060 | Abdominal pain | |
| 119720609 | 11972060 | Abdominal pain upper | |
| 119720609 | 11972060 | Anaemia | |
| 119720609 | 11972060 | Anxiety | |
| 119720609 | 11972060 | Arthralgia | |
| 119720609 | 11972060 | Back pain | |
| 119720609 | 11972060 | Bone pain | |
| 119720609 | 11972060 | Burning sensation | |
| 119720609 | 11972060 | Chest pain | |
| 119720609 | 11972060 | Dizziness | |
| 119720609 | 11972060 | Ear pain | |
| 119720609 | 11972060 | Fatigue | |
| 119720609 | 11972060 | Granuloma skin | |
| 119720609 | 11972060 | Menstrual disorder | |
| 119720609 | 11972060 | Nervousness | |
| 119720609 | 11972060 | Oedema peripheral | |
| 119720609 | 11972060 | Oropharyngeal pain | |
| 119720609 | 11972060 | Ovarian cyst | |
| 119720609 | 11972060 | Pelvic fluid collection | |
| 119720609 | 11972060 | Pelvic pain | |
| 119720609 | 11972060 | Rectal haemorrhage | |
| 119720609 | 11972060 | Splenomegaly | |
| 119720609 | 11972060 | Thyroid disorder | |
| 119720609 | 11972060 | Tooth disorder | |
| 119720609 | 11972060 | Vaginal infection | |
| 119720609 | 11972060 | 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 |
|---|---|---|---|---|---|---|
| 119720609 | 11972060 | 1 | 20160113 | 0 | ||
| 119720609 | 11972060 | 2 | 2007 | 0 | ||
| 119720609 | 11972060 | 3 | 20160118 | 0 |