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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118694085 | 11869408 | 5 | F | 20150623 | 20160919 | 20151227 | 20160923 | PER | PHHY2015US099102 | NOVARTIS | 42.92 | YR | F | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118694085 | 11869408 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 118694085 | 11869408 | 2 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 1000 MG, UNK | Y | 0 | 1000 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118694085 | 11869408 | 1 | Multiple sclerosis |
| 118694085 | 11869408 | 2 | Multiple sclerosis relapse |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118694085 | 11869408 | Abdominal discomfort | |
| 118694085 | 11869408 | Alanine aminotransferase increased | |
| 118694085 | 11869408 | Asthenia | |
| 118694085 | 11869408 | Burning sensation | |
| 118694085 | 11869408 | Cafe au lait spots | |
| 118694085 | 11869408 | Constipation | |
| 118694085 | 11869408 | Depression | |
| 118694085 | 11869408 | Diplopia | |
| 118694085 | 11869408 | Gait disturbance | |
| 118694085 | 11869408 | Haemangioma of skin | |
| 118694085 | 11869408 | Headache | |
| 118694085 | 11869408 | Lentigo | |
| 118694085 | 11869408 | Lymphocyte count decreased | |
| 118694085 | 11869408 | Melanocytic naevus | |
| 118694085 | 11869408 | Muscle spasms | |
| 118694085 | 11869408 | Nausea | |
| 118694085 | 11869408 | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 118694085 | 11869408 | 2 | 20151123 | 20151125 | 0 |