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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121203096 | 12120309 | 6 | F | 201511 | 20160728 | 20160226 | 20160729 | PER | PHEH2016US004707 | NOVARTIS | 47.10 | YR | F | Y | 89.50000 | KG | 20160729 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121203096 | 12120309 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 121203096 | 12120309 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | SO121 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 121203096 | 12120309 | 3 | C | TOPAMAX | TOPIRAMATE | 1 | Oral | 100 MG, BID | U | 0 | 100 | MG | BID | ||||||
| 121203096 | 12120309 | 4 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Oral | 17 G, QD | U | 0 | 17 | G | QD | ||||||
| 121203096 | 12120309 | 5 | C | VERAPAMIL | VERAPAMIL HYDROCHLORIDE | 1 | Oral | 80 MG, TID | 0 | 80 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121203096 | 12120309 | 1 | Multiple sclerosis |
| 121203096 | 12120309 | 3 | Headache |
| 121203096 | 12120309 | 4 | Constipation |
| 121203096 | 12120309 | 5 | Migraine |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121203096 | 12120309 | Chest pain | |
| 121203096 | 12120309 | Dizziness | |
| 121203096 | 12120309 | Dyspnoea | |
| 121203096 | 12120309 | Malaise |
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 |
|---|---|---|---|---|---|---|
| 121203096 | 12120309 | 1 | 20150429 | 0 | ||
| 121203096 | 12120309 | 2 | 20160318 | 0 | ||
| 121203096 | 12120309 | 4 | 20160307 | 0 | ||
| 121203096 | 12120309 | 5 | 20160624 | 0 |