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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127543512 | 12754351 | 2 | F | 201505 | 20160920 | 20160916 | 20160928 | EXP | PHHY2016BR033268 | NOVARTIS | 57.97 | YR | F | Y | 72.00000 | KG | 20160928 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127543512 | 12754351 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 3 DF, QD | 22068 | 3 | DF | CAPSULE | QD | ||||||
| 127543512 | 12754351 | 2 | SS | TASIGNA | NILOTINIB | 1 | Unknown | 200 MG, BID (2 DF) | 22068 | 200 | MG | CAPSULE | BID | ||||||
| 127543512 | 12754351 | 3 | SS | TASIGNA | NILOTINIB | 1 | Oral | 1 DF, QD | 22068 | 1 | DF | CAPSULE | QD | ||||||
| 127543512 | 12754351 | 4 | SS | IMATINIB MESYLATE. | IMATINIB MESYLATE | 1 | Unknown | 400 MG, UNK | Y | 0 | 400 | MG | |||||||
| 127543512 | 12754351 | 5 | SS | IMATINIB MESYLATE. | IMATINIB MESYLATE | 1 | Unknown | 100 MG, UNK | Y | 0 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127543512 | 12754351 | 1 | Chronic myeloid leukaemia |
| 127543512 | 12754351 | 4 | Chronic myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127543512 | 12754351 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127543512 | 12754351 | Anaemia | |
| 127543512 | 12754351 | Asthenia | |
| 127543512 | 12754351 | Bone marrow disorder | |
| 127543512 | 12754351 | Contusion | |
| 127543512 | 12754351 | Decreased appetite | |
| 127543512 | 12754351 | Disorientation | |
| 127543512 | 12754351 | Dizziness | |
| 127543512 | 12754351 | Drug ineffective | |
| 127543512 | 12754351 | Feeling abnormal | |
| 127543512 | 12754351 | Glaucoma | |
| 127543512 | 12754351 | Headache | |
| 127543512 | 12754351 | Increased tendency to bruise | |
| 127543512 | 12754351 | Limb injury | |
| 127543512 | 12754351 | Malaise | |
| 127543512 | 12754351 | Nausea | |
| 127543512 | 12754351 | Pain | |
| 127543512 | 12754351 | Pigmentation disorder | |
| 127543512 | 12754351 | Platelet count decreased | |
| 127543512 | 12754351 | Retching | |
| 127543512 | 12754351 | Traumatic haemorrhage | |
| 127543512 | 12754351 | Vomiting | |
| 127543512 | 12754351 | Weight decreased | |
| 127543512 | 12754351 | Weight increased | |
| 127543512 | 12754351 | 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 |
|---|---|---|---|---|---|---|
| 127543512 | 12754351 | 2 | 20151115 | 0 |