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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119412245 | 11941224 | 5 | F | 2016 | 20160715 | 20160122 | 20160725 | EXP | PHEH2016US001744 | NOVARTIS | 52.22 | YR | M | Y | 0.00000 | 20160725 | MD | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119412245 | 11941224 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | 22527 | .5 | MG | CAPSULE | QD | |||||
| 119412245 | 11941224 | 2 | SS | AMPYRA | DALFAMPRIDINE | 1 | Oral | 10 MG, BID | Y | 0 | 10 | MG | TABLET | BID | |||||
| 119412245 | 11941224 | 3 | SS | AMPYRA | DALFAMPRIDINE | 1 | Y | 0 | TABLET | ||||||||||
| 119412245 | 11941224 | 4 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | 30 MG, TID | 0 | 30 | MG | TID | |||||||
| 119412245 | 11941224 | 5 | C | DANTROLENE SODIUM. | DANTROLENE SODIUM | 1 | Unknown | 50 MG, QD | 0 | 50 | MG | QD | |||||||
| 119412245 | 11941224 | 6 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | 500 UG, QD | 0 | 500 | UG | QD | |||||||
| 119412245 | 11941224 | 7 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | 2000 IU, QD | 0 | 2000 | IU | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119412245 | 11941224 | 1 | Multiple sclerosis |
| 119412245 | 11941224 | 2 | Gait disturbance |
| 119412245 | 11941224 | 3 | Multiple sclerosis |
| 119412245 | 11941224 | 4 | Product used for unknown indication |
| 119412245 | 11941224 | 5 | Product used for unknown indication |
| 119412245 | 11941224 | 6 | Product used for unknown indication |
| 119412245 | 11941224 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119412245 | 11941224 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119412245 | 11941224 | Back pain | |
| 119412245 | 11941224 | Bundle branch block right | |
| 119412245 | 11941224 | Concomitant disease aggravated | |
| 119412245 | 11941224 | Dizziness | |
| 119412245 | 11941224 | Dysstasia | |
| 119412245 | 11941224 | Electrocardiogram abnormal | |
| 119412245 | 11941224 | Gait disturbance | |
| 119412245 | 11941224 | Myocardial infarction | |
| 119412245 | 11941224 | Nausea | |
| 119412245 | 11941224 | Pain in extremity | |
| 119412245 | 11941224 | Speech disorder |
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 |
|---|---|---|---|---|---|---|
| 119412245 | 11941224 | 1 | 20160114 | 0 | ||
| 119412245 | 11941224 | 2 | 201401 | 0 |