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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123591734 | 12359173 | 4 | F | 20160116 | 20160701 | 20160512 | 20160706 | EXP | PHHY2016IT062256 | NOVARTIS | 25.55 | YR | F | Y | 0.00000 | 20160706 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123591734 | 12359173 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 460.5 | MG | Y | 22527 | .5 | MG | CAPSULE | QD | |||
| 123591734 | 12359173 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QOD | 460.5 | MG | Y | 22527 | .5 | MG | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123591734 | 12359173 | 1 | Relapsing-remitting multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123591734 | 12359173 | HO |
| 123591734 | 12359173 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123591734 | 12359173 | Haemoglobin decreased | |
| 123591734 | 12359173 | Hyperplasia | |
| 123591734 | 12359173 | Immune thrombocytopenic purpura | |
| 123591734 | 12359173 | Multiple sclerosis relapse | |
| 123591734 | 12359173 | Petechiae | |
| 123591734 | 12359173 | Prescribed underdose | |
| 123591734 | 12359173 | Red blood cell count decreased | |
| 123591734 | 12359173 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 123591734 | 12359173 | 1 | 20130710 | 0 | ||
| 123591734 | 12359173 | 2 | 201603 | 20160331 | 0 |