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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113343236 | 11334323 | 6 | F | 20140910 | 20160919 | 20150803 | 20160921 | PER | PHHY2014US159839 | NOVARTIS | 36.18 | YR | F | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113343236 | 11334323 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 113343236 | 11334323 | 2 | C | KENALOG | TRIAMCINOLONE ACETONIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113343236 | 11334323 | 3 | C | TRIAMCINOLONE | TRIAMCINOLONE | 1 | Unknown | UNK | U | 0 | CREAM |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113343236 | 11334323 | 1 | Multiple sclerosis |
| 113343236 | 11334323 | 2 | Dermatitis |
| 113343236 | 11334323 | 3 | Dermatitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113343236 | 11334323 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113343236 | 11334323 | Alanine aminotransferase increased | |
| 113343236 | 11334323 | Aspartate aminotransferase increased | |
| 113343236 | 11334323 | Gait disturbance | |
| 113343236 | 11334323 | Headache | |
| 113343236 | 11334323 | Lymphopenia | |
| 113343236 | 11334323 | Mental impairment | |
| 113343236 | 11334323 | Muscular weakness | |
| 113343236 | 11334323 | Nausea | |
| 113343236 | 11334323 | Skin lesion | |
| 113343236 | 11334323 | White blood cell count 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 |
|---|---|---|---|---|---|---|
| 113343236 | 11334323 | 2 | 20141007 | 0 | ||
| 113343236 | 11334323 | 3 | 20141007 | 0 |