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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120609083 | 12060908 | 3 | F | 201602 | 20160705 | 20160210 | 20160713 | PER | PHEH2016US003120 | NOVARTIS | 46.50 | YR | F | Y | 0.00000 | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120609083 | 12060908 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 120609083 | 12060908 | 2 | C | MELATONIN | MELATONIN | 1 | FREQUENCY: HS (AT BEDTIME) | U | 0 | QD | |||||||||
| 120609083 | 12060908 | 3 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | U | 0 | |||||||||||
| 120609083 | 12060908 | 4 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 120609083 | 12060908 | 5 | C | BACLOFEN. | BACLOFEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120609083 | 12060908 | 1 | Multiple sclerosis |
| 120609083 | 12060908 | 2 | Product used for unknown indication |
| 120609083 | 12060908 | 3 | Product used for unknown indication |
| 120609083 | 12060908 | 4 | Product used for unknown indication |
| 120609083 | 12060908 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120609083 | 12060908 | Dizziness | |
| 120609083 | 12060908 | Fatigue | |
| 120609083 | 12060908 | Flushing | |
| 120609083 | 12060908 | Headache | |
| 120609083 | 12060908 | Heart rate decreased | |
| 120609083 | 12060908 | Hypotension |
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 |
|---|---|---|---|---|---|---|
| 120609083 | 12060908 | 1 | 20160205 | 0 |