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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121653673 | 12165367 | 3 | F | 201603 | 20160630 | 20160309 | 20160707 | PER | PHEH2016US005666 | NOVARTIS | 28.36 | YR | M | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121653673 | 12165367 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | U | 22527 | .5 | MG | CAPSULE | QD | |||||
| 121653673 | 12165367 | 2 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121653673 | 12165367 | 1 | Multiple sclerosis |
| 121653673 | 12165367 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121653673 | 12165367 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121653673 | 12165367 | Balance disorder | |
| 121653673 | 12165367 | Chest discomfort | |
| 121653673 | 12165367 | Depressed mood | |
| 121653673 | 12165367 | Disturbance in attention | |
| 121653673 | 12165367 | Dyspnoea | |
| 121653673 | 12165367 | Fatigue | |
| 121653673 | 12165367 | Hand-eye coordination impaired | |
| 121653673 | 12165367 | Heart rate decreased | |
| 121653673 | 12165367 | Hypoaesthesia | |
| 121653673 | 12165367 | Influenza like illness | |
| 121653673 | 12165367 | Multiple sclerosis relapse | |
| 121653673 | 12165367 | Musculoskeletal stiffness | |
| 121653673 | 12165367 | Paraesthesia |
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 |
|---|---|---|---|---|---|---|
| 121653673 | 12165367 | 1 | 20160305 | 0 |