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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127616461 | 12761646 | 1 | I | 20160814 | 20160520 | 20160920 | 20160920 | EXP | PHHY2016PT071729 | NOVARTIS | 25.00 | YR | F | Y | 0.00000 | 20160920 | CN | PT | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127616461 | 12761646 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 127616461 | 12761646 | 2 | SS | ALPRAZOLAM. | ALPRAZOLAM | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127616461 | 12761646 | 1 | Multiple sclerosis |
| 127616461 | 12761646 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127616461 | 12761646 | OT |
| 127616461 | 12761646 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127616461 | 12761646 | Anxiety | |
| 127616461 | 12761646 | Chest discomfort | |
| 127616461 | 12761646 | Depression | |
| 127616461 | 12761646 | Dizziness | |
| 127616461 | 12761646 | Hemiparesis | |
| 127616461 | 12761646 | Nausea | |
| 127616461 | 12761646 | Seizure | |
| 127616461 | 12761646 | Tongue movement disturbance | |
| 127616461 | 12761646 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 127616461 | 12761646 | 1 | 20160303 | 0 | ||
| 127616461 | 12761646 | 2 | 20160908 | 0 |