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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116423956 | 11642395 | 6 | F | 20150411 | 20160719 | 20151019 | 20160725 | PER | PHHY2015US123720 | NOVARTIS | 33.60 | YR | F | Y | 0.00000 | 20160726 | MD | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116423956 | 11642395 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | UNK, QD | 22527 | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116423956 | 11642395 | 1 | Multiple sclerosis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116423956 | 11642395 | Alanine aminotransferase increased | |
| 116423956 | 11642395 | Anxiety | |
| 116423956 | 11642395 | Aspartate aminotransferase increased | |
| 116423956 | 11642395 | Blood alkaline phosphatase decreased | |
| 116423956 | 11642395 | Chest pain | |
| 116423956 | 11642395 | Contusion | |
| 116423956 | 11642395 | Disturbance in attention | |
| 116423956 | 11642395 | Dizziness | |
| 116423956 | 11642395 | Fatigue | |
| 116423956 | 11642395 | Hypoaesthesia | |
| 116423956 | 11642395 | Melanocytic naevus | |
| 116423956 | 11642395 | Muscle spasms | |
| 116423956 | 11642395 | Nausea | |
| 116423956 | 11642395 | Rectal discharge | |
| 116423956 | 11642395 | Seasonal allergy | |
| 116423956 | 11642395 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |