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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114858118 | 11485811 | 8 | F | 20160614 | 20160628 | 20150910 | 20160705 | EXP | PHEH2015US017513 | NOVARTIS | 49.84 | YR | F | Y | 78.70000 | KG | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114858118 | 11485811 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | S0015 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 114858118 | 11485811 | 2 | SS | VICODIN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | TID | U | 0 | TID | ||||||||
| 114858118 | 11485811 | 3 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Unknown | 90 MG, QD | 0 | 90 | MG | QD | |||||||
| 114858118 | 11485811 | 4 | C | TIZANIDINE. | TIZANIDINE | 1 | Unknown | 2 MG, BID | 0 | 2 | MG | BID | |||||||
| 114858118 | 11485811 | 5 | C | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Unknown | 400 MG, BID | U | 0 | 400 | MG | BID | ||||||
| 114858118 | 11485811 | 6 | C | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | BID | U | 0 | BID | ||||||||
| 114858118 | 11485811 | 7 | C | ABILIFY | ARIPIPRAZOLE | 1 | Oral | QD | U | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114858118 | 11485811 | 1 | Multiple sclerosis |
| 114858118 | 11485811 | 2 | Product used for unknown indication |
| 114858118 | 11485811 | 3 | Product used for unknown indication |
| 114858118 | 11485811 | 4 | Product used for unknown indication |
| 114858118 | 11485811 | 5 | Product used for unknown indication |
| 114858118 | 11485811 | 6 | Product used for unknown indication |
| 114858118 | 11485811 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114858118 | 11485811 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114858118 | 11485811 | Central nervous system lesion | |
| 114858118 | 11485811 | Cognitive disorder | |
| 114858118 | 11485811 | Disturbance in attention | |
| 114858118 | 11485811 | Fall | |
| 114858118 | 11485811 | Lymphocyte count decreased | |
| 114858118 | 11485811 | Memory impairment | |
| 114858118 | 11485811 | Mental disorder | |
| 114858118 | 11485811 | Mental impairment |
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 |
|---|---|---|---|---|---|---|
| 114858118 | 11485811 | 1 | 20150827 | 0 | ||
| 114858118 | 11485811 | 3 | 2013 | 0 | ||
| 114858118 | 11485811 | 4 | 2013 | 0 |