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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115166934 | 11516693 | 4 | F | 201502 | 20160812 | 20150917 | 20160819 | EXP | PHHY2015DE111674 | NOVARTIS | 0.00 | E | F | Y | 0.00000 | 20160819 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115166934 | 11516693 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 600 MG, QD | Y | 22068 | 600 | MG | CAPSULE | QD | |||||
| 115166934 | 11516693 | 2 | C | TAMOXIFEN | TAMOXIFEN | 1 | Unknown | 20 MG, UNK | 0 | 20 | MG | ||||||||
| 115166934 | 11516693 | 3 | C | BISOPROLOL | BISOPROLOL | 1 | Unknown | 5 MG, UNK | 0 | 5 | MG | ||||||||
| 115166934 | 11516693 | 4 | C | BISOPROLOL COMP | 2 | Unknown | 5 MG, UNK | 0 | 5 | MG | |||||||||
| 115166934 | 11516693 | 5 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 2.5 MG, UNK | 0 | 2.5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115166934 | 11516693 | 1 | Chronic myeloid leukaemia |
| 115166934 | 11516693 | 2 | Product used for unknown indication |
| 115166934 | 11516693 | 3 | Product used for unknown indication |
| 115166934 | 11516693 | 4 | Product used for unknown indication |
| 115166934 | 11516693 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115166934 | 11516693 | Rash | |
| 115166934 | 11516693 | Rash pruritic | |
| 115166934 | 11516693 | Toxicity to various agents |
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 |
|---|---|---|---|---|---|---|
| 115166934 | 11516693 | 1 | 20150209 | 20160317 | 0 | |
| 115166934 | 11516693 | 2 | 201308 | 0 |