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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115373052 | 11537305 | 2 | F | 20150305 | 20160902 | 20150922 | 20160908 | PER | PHEH2015US003899 | NOVARTIS | 63.64 | YR | F | Y | 83.45000 | KG | 20160908 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115373052 | 11537305 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | S0087, S0090 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 115373052 | 11537305 | 2 | C | ADVIL COLD | 2 | Unknown | U | 0 | |||||||||||
| 115373052 | 11537305 | 3 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | U | 0 | ||||||||||
| 115373052 | 11537305 | 4 | C | VITAMIN B | VITAMIN B | 1 | Unknown | 5000 MG, UNK | U | 0 | 5000 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115373052 | 11537305 | 1 | Multiple sclerosis |
| 115373052 | 11537305 | 2 | Product used for unknown indication |
| 115373052 | 11537305 | 3 | Product used for unknown indication |
| 115373052 | 11537305 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115373052 | 11537305 | Balance disorder | |
| 115373052 | 11537305 | Cataract | |
| 115373052 | 11537305 | Chest pain | |
| 115373052 | 11537305 | Diplopia | |
| 115373052 | 11537305 | Dyspnoea | |
| 115373052 | 11537305 | Eye disorder | |
| 115373052 | 11537305 | Fall | |
| 115373052 | 11537305 | Fatigue | |
| 115373052 | 11537305 | Hallucination, visual | |
| 115373052 | 11537305 | Head discomfort | |
| 115373052 | 11537305 | Memory impairment | |
| 115373052 | 11537305 | Visual impairment | |
| 115373052 | 11537305 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 115373052 | 11537305 | 1 | 20150213 | 0 |