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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94337854 | 9433785 | 4 | F | 20130613 | 20160816 | 20130731 | 20160822 | EXP | PHHY2013CA062485 | NOVARTIS | 45.59 | YR | F | Y | 0.00000 | 20160822 | MD | CA | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94337854 | 9433785 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 21.5 | MG | 22527 | .5 | MG | CAPSULE | QD | ||||
| 94337854 | 9433785 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 21.5 | MG | 22527 | .5 | MG | CAPSULE | QD | ||||
| 94337854 | 9433785 | 3 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 1.5 DF, QID | 0 | 1.5 | DF | QID | |||||||
| 94337854 | 9433785 | 4 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | 20 MG, QID | 0 | 20 | MG | QID | |||||||
| 94337854 | 9433785 | 5 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 300 MG, TID | 0 | 300 | MG | TID | |||||||
| 94337854 | 9433785 | 6 | C | ATIVAN | LORAZEPAM | 1 | Unknown | 1 MG, PRN | 0 | 1 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 94337854 | 9433785 | 1 | Relapsing-remitting multiple sclerosis |
| 94337854 | 9433785 | 3 | Product used for unknown indication |
| 94337854 | 9433785 | 4 | Product used for unknown indication |
| 94337854 | 9433785 | 5 | Product used for unknown indication |
| 94337854 | 9433785 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 94337854 | 9433785 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 94337854 | 9433785 | Abasia | |
| 94337854 | 9433785 | Glaucoma | |
| 94337854 | 9433785 | Hypoaesthesia | |
| 94337854 | 9433785 | Lymphocyte count decreased | |
| 94337854 | 9433785 | Paraesthesia | |
| 94337854 | 9433785 | Peripheral swelling | |
| 94337854 | 9433785 | Vision blurred | |
| 94337854 | 9433785 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 94337854 | 9433785 | 1 | 20130606 | 20130719 | 0 | |
| 94337854 | 9433785 | 2 | 20130820 | 0 |