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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126805051 | 12680505 | 1 | I | 201509 | 20151110 | 20160824 | 20160824 | EXP | PHHY2015CO149480 | NOVARTIS | 39.71 | YR | F | Y | 54.00000 | KG | 20160824 | CN | COUNTRY NOT SPECIFIED | CO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126805051 | 12680505 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 2 DF (150 MG), QD (EVERY 24 HOURS) | S0030 | 22068 | 2 | DF | CAPSULE | QD | |||||
| 126805051 | 12680505 | 2 | SS | TASIGNA | NILOTINIB | 1 | Oral | 2 DF (150 MG), Q12H (EVERY 12 HOURS) | 22068 | 2 | DF | CAPSULE | Q12H | ||||||
| 126805051 | 12680505 | 3 | C | ISONIAZID. | ISONIAZID | 1 | Unknown | 300 MG, QD (1 DAILY) | 25801.6406 | MG | Y | 0 | 300 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126805051 | 12680505 | 1 | Chronic myeloid leukaemia |
| 126805051 | 12680505 | 3 | Latent tuberculosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126805051 | 12680505 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126805051 | 12680505 | Blood bilirubin increased | |
| 126805051 | 12680505 | Chest pain | |
| 126805051 | 12680505 | Discomfort | |
| 126805051 | 12680505 | Drug-induced liver injury | |
| 126805051 | 12680505 | Fatigue | |
| 126805051 | 12680505 | Headache | |
| 126805051 | 12680505 | Hepatic pain | |
| 126805051 | 12680505 | Incorrect drug administration duration | |
| 126805051 | 12680505 | Liver disorder | |
| 126805051 | 12680505 | Liver function test abnormal | |
| 126805051 | 12680505 | Movement disorder | |
| 126805051 | 12680505 | Nausea | |
| 126805051 | 12680505 | Pain in extremity | |
| 126805051 | 12680505 | Rash |
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 |
|---|---|---|---|---|---|---|
| 126805051 | 12680505 | 1 | 20150808 | 0 | ||
| 126805051 | 12680505 | 3 | 20150804 | 20151110 | 0 |