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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127569431 | 12756943 | 1 | I | 20131104 | 20160917 | 20160917 | EXP | PHHY2013CA126920 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160918 | CN | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127569431 | 12756943 | 1 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | U | 0 | .5 | MG | CAPSULE | QD | |||||
| 127569431 | 12756943 | 2 | PS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Unknown | Y | 10187 | ||||||||||
| 127569431 | 12756943 | 3 | SS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Unknown | 150 MG, FOR A WEEK | 0 | 150 | MG | ||||||||
| 127569431 | 12756943 | 4 | SS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Unknown | 300 MG, UNK | 0 | 300 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127569431 | 12756943 | 1 | Relapsing-remitting multiple sclerosis |
| 127569431 | 12756943 | 2 | Fatigue |
| 127569431 | 12756943 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127569431 | 12756943 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127569431 | 12756943 | Depressed mood | |
| 127569431 | 12756943 | Fatigue | |
| 127569431 | 12756943 | Hypoaesthesia | |
| 127569431 | 12756943 | Insomnia | |
| 127569431 | 12756943 | Multiple sclerosis relapse | |
| 127569431 | 12756943 | Rash | |
| 127569431 | 12756943 | Restless legs syndrome | |
| 127569431 | 12756943 | Restlessness | |
| 127569431 | 12756943 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 127569431 | 12756943 | 1 | 20121115 | 0 | ||
| 127569431 | 12756943 | 3 | 20130924 | 0 |