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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121611372 | 12161137 | 2 | F | 20160216 | 20160822 | 20160308 | 20160826 | EXP | PHEH2016US005447 | NOVARTIS | 39.06 | YR | F | Y | 0.00000 | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121611372 | 12161137 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | 22527 | .5 | MG | CAPSULE | QD | |||||
| 121611372 | 12161137 | 2 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121611372 | 12161137 | 1 | Multiple sclerosis |
| 121611372 | 12161137 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121611372 | 12161137 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121611372 | 12161137 | Anxiety | |
| 121611372 | 12161137 | Ataxia | |
| 121611372 | 12161137 | Blindness | |
| 121611372 | 12161137 | Cognitive disorder | |
| 121611372 | 12161137 | Concomitant disease aggravated | |
| 121611372 | 12161137 | Depression | |
| 121611372 | 12161137 | Fatigue | |
| 121611372 | 12161137 | Gait disturbance | |
| 121611372 | 12161137 | Hypoaesthesia | |
| 121611372 | 12161137 | Memory impairment | |
| 121611372 | 12161137 | Muscle spasms | |
| 121611372 | 12161137 | Optic neuritis | |
| 121611372 | 12161137 | Otorrhoea | |
| 121611372 | 12161137 | Pain | |
| 121611372 | 12161137 | Paraesthesia | |
| 121611372 | 12161137 | Sinusitis | |
| 121611372 | 12161137 | Upper respiratory tract infection | |
| 121611372 | 12161137 | Vitamin B complex deficiency | |
| 121611372 | 12161137 | Vitamin D 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 |
|---|---|---|---|---|---|---|
| 121611372 | 12161137 | 1 | 20151209 | 0 |