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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122050044 | 12205004 | 4 | F | 20160319 | 20160829 | 20160323 | 20160902 | PER | PHEH2016US007041 | NOVARTIS | 41.30 | YR | F | Y | 0.00000 | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122050044 | 12205004 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 122050044 | 12205004 | 2 | C | AMPYRA | DALFAMPRIDINE | 1 | Oral | 10 MG, BID | Y | 0 | 10 | MG | BID | ||||||
| 122050044 | 12205004 | 3 | C | AMPYRA | DALFAMPRIDINE | 1 | Y | 0 | |||||||||||
| 122050044 | 12205004 | 4 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | UNK | U | 0 | |||||||||
| 122050044 | 12205004 | 5 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122050044 | 12205004 | 1 | Multiple sclerosis |
| 122050044 | 12205004 | 2 | Gait disturbance |
| 122050044 | 12205004 | 3 | Multiple sclerosis |
| 122050044 | 12205004 | 4 | Product used for unknown indication |
| 122050044 | 12205004 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122050044 | 12205004 | Acne cystic | |
| 122050044 | 12205004 | Fatigue | |
| 122050044 | 12205004 | Feeling jittery | |
| 122050044 | 12205004 | Heart rate decreased | |
| 122050044 | 12205004 | Hypotension | |
| 122050044 | 12205004 | Ocular discomfort |
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 |
|---|---|---|---|---|---|---|
| 122050044 | 12205004 | 1 | 20160319 | 0 | ||
| 122050044 | 12205004 | 2 | 201601 | 20160320 | 0 |