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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123709893 | 12370989 | 3 | F | 201606 | 20160804 | 20160516 | 20160810 | PER | PHEH2016US011926 | NOVARTIS | 58.83 | YR | M | Y | 86.62000 | KG | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123709893 | 12370989 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 123709893 | 12370989 | 2 | SS | AMPYRA | DALFAMPRIDINE | 1 | Oral | 10 MG, BID | 0 | 10 | MG | EXTENDED RELEASE TABLET | BID | ||||||
| 123709893 | 12370989 | 3 | SS | TECFIDERA | DIMETHYL FUMARATE | 1 | Oral | 240 MG, BID | U | 0 | 240 | MG | BID | ||||||
| 123709893 | 12370989 | 4 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 300 MG, QID | U | 0 | 300 | MG | QID | ||||||
| 123709893 | 12370989 | 5 | C | ALEVE | NAPROXEN SODIUM | 1 | Unknown | 220 MG, BID | U | 0 | 220 | MG | TABLET | BID | |||||
| 123709893 | 12370989 | 6 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 2000 IU, QD | U | 0 | 2000 | IU | QD | ||||||
| 123709893 | 12370989 | 7 | C | RAPAFLO | SILODOSIN | 1 | Unknown | UNK, QD | U | 0 | QD | ||||||||
| 123709893 | 12370989 | 8 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | 10 MG, QOD | U | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123709893 | 12370989 | 1 | Multiple sclerosis |
| 123709893 | 12370989 | 2 | Multiple sclerosis |
| 123709893 | 12370989 | 3 | Product used for unknown indication |
| 123709893 | 12370989 | 4 | Product used for unknown indication |
| 123709893 | 12370989 | 5 | Pain |
| 123709893 | 12370989 | 6 | Product used for unknown indication |
| 123709893 | 12370989 | 7 | Product used for unknown indication |
| 123709893 | 12370989 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123709893 | 12370989 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123709893 | 12370989 | Back pain | |
| 123709893 | 12370989 | Balance disorder | |
| 123709893 | 12370989 | Body temperature abnormal | |
| 123709893 | 12370989 | Constipation | |
| 123709893 | 12370989 | Depressed level of consciousness | |
| 123709893 | 12370989 | Dyspepsia | |
| 123709893 | 12370989 | Dysphagia | |
| 123709893 | 12370989 | Eye swelling | |
| 123709893 | 12370989 | Fall | |
| 123709893 | 12370989 | Fatigue | |
| 123709893 | 12370989 | Flushing | |
| 123709893 | 12370989 | Gait disturbance | |
| 123709893 | 12370989 | Herpes zoster | |
| 123709893 | 12370989 | Paraesthesia | |
| 123709893 | 12370989 | Peripheral coldness | |
| 123709893 | 12370989 | Rash | |
| 123709893 | 12370989 | Sensory disturbance |
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 |
|---|---|---|---|---|---|---|
| 123709893 | 12370989 | 1 | 20130802 | 0 | ||
| 123709893 | 12370989 | 2 | 2013 | 0 | ||
| 123709893 | 12370989 | 3 | 201606 | 0 |