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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 802646321 | 8026463 | 21 | F | 20110627 | 20160711 | 20110708 | 20160718 | EXP | PHHY2011CA58234 | NOVARTIS | 54.93 | YR | F | Y | 0.00000 | 20160718 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 802646321 | 8026463 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | S0006CA2 | 22527 | .5 | MG | CAPSULE | QD | ||||
| 802646321 | 8026463 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | 22527 | .5 | MG | CAPSULE | QD | |||||
| 802646321 | 8026463 | 3 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | UNK | Y | 22527 | CAPSULE | ||||||||
| 802646321 | 8026463 | 4 | SS | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 802646321 | 8026463 | 5 | C | FAMPYRA | DALFAMPRIDINE | 1 | Unknown | 10 MG, BID | U | 0 | 10 | MG | BID | ||||||
| 802646321 | 8026463 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 400 MG, TID | U | 0 | 400 | MG | TID | ||||||
| 802646321 | 8026463 | 7 | C | AMITRIPTYLENE | AMITRIPTYLINE | 1 | Unknown | 35 MG, QHS | U | 0 | 35 | MG | |||||||
| 802646321 | 8026463 | 8 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | PRN | U | 0 | |||||||||
| 802646321 | 8026463 | 9 | C | SATIVEX | NABIXIMOLS | 1 | Oral | PRN | U | 0 | |||||||||
| 802646321 | 8026463 | 10 | C | ACTONEL | RISEDRONATE SODIUM | 1 | Unknown | 35 MG, WEEKLY | U | 0 | 35 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 802646321 | 8026463 | 1 | Relapsing-remitting multiple sclerosis |
| 802646321 | 8026463 | 4 | Product used for unknown indication |
| 802646321 | 8026463 | 5 | Product used for unknown indication |
| 802646321 | 8026463 | 6 | Product used for unknown indication |
| 802646321 | 8026463 | 7 | Product used for unknown indication |
| 802646321 | 8026463 | 8 | Product used for unknown indication |
| 802646321 | 8026463 | 9 | Product used for unknown indication |
| 802646321 | 8026463 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 802646321 | 8026463 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 802646321 | 8026463 | Blood pressure decreased | |
| 802646321 | 8026463 | Central nervous system lesion | |
| 802646321 | 8026463 | Contusion | |
| 802646321 | 8026463 | Dizziness | |
| 802646321 | 8026463 | Drug ineffective | |
| 802646321 | 8026463 | Erythema | |
| 802646321 | 8026463 | Fatigue | |
| 802646321 | 8026463 | Fine motor skill dysfunction | |
| 802646321 | 8026463 | Heart rate decreased | |
| 802646321 | 8026463 | Hypoaesthesia | |
| 802646321 | 8026463 | Impaired healing | |
| 802646321 | 8026463 | Lymphocyte count decreased | |
| 802646321 | 8026463 | Multiple sclerosis relapse | |
| 802646321 | 8026463 | Muscular weakness | |
| 802646321 | 8026463 | Neutrophil count decreased | |
| 802646321 | 8026463 | Oral herpes | |
| 802646321 | 8026463 | Skin injury | |
| 802646321 | 8026463 | Somnolence | |
| 802646321 | 8026463 | Visual impairment | |
| 802646321 | 8026463 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 802646321 | 8026463 | 1 | 20110627 | 0 | ||
| 802646321 | 8026463 | 2 | 20111201 | 20151102 | 0 | |
| 802646321 | 8026463 | 3 | 20160510 | 20160604 | 0 |