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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116973217 | 11697321 | 7 | F | 20151030 | 20160629 | 20151104 | 20160711 | PER | PHEH2015US022479 | NOVARTIS | 59.92 | YR | M | Y | 70.30000 | KG | 20160712 | CN | COUNTRY NOT SPECIFIED | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116973217 | 11697321 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | F0017, F0023 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 116973217 | 11697321 | 2 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | U | 0 | ||||||||||
| 116973217 | 11697321 | 3 | C | ASPIRIN//ACETYLSALICYLIC ACID | ASPIRIN | 1 | Unknown | 81 MG, UNK | U | 0 | 81 | MG | |||||||
| 116973217 | 11697321 | 4 | C | FISH OIL | FISH OIL | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116973217 | 11697321 | 1 | Multiple sclerosis |
| 116973217 | 11697321 | 2 | Product used for unknown indication |
| 116973217 | 11697321 | 3 | Product used for unknown indication |
| 116973217 | 11697321 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116973217 | 11697321 | Blindness transient | |
| 116973217 | 11697321 | Dysphagia | |
| 116973217 | 11697321 | Headache | |
| 116973217 | 11697321 | Inflammation | |
| 116973217 | 11697321 | Palpitations | |
| 116973217 | 11697321 | Urinary tract infection | |
| 116973217 | 11697321 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 116973217 | 11697321 | 1 | 20151030 | 0 |