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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118683326 | 11868332 | 6 | F | 20130415 | 20160629 | 20151224 | 20160705 | EXP | PHJP2015JP022537 | NOVARTIS | 71.23 | YR | F | Y | 0.00000 | 20160705 | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118683326 | 11868332 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 6 | MG | Y | U | 22527 | .5 | MG | CAPSULE | QD | ||
| 118683326 | 11868332 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QOD | 6 | MG | Y | U | 22527 | .5 | MG | CAPSULE | |||
| 118683326 | 11868332 | 3 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 6 | MG | Y | U | 22527 | .5 | MG | CAPSULE | QD | ||
| 118683326 | 11868332 | 4 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, ONCE 5 DAYS | 6 | MG | Y | U | 22527 | .5 | MG | CAPSULE | |||
| 118683326 | 11868332 | 5 | C | CINAL | ASCORBIC ACIDCALCIUM PANTOTHENATE | 1 | Oral | 6 DF, UNK | 0 | 6 | DF | TABLET | |||||||
| 118683326 | 11868332 | 6 | C | MAGLAX | MAGNESIUM OXIDE | 1 | Oral | 500 MG, UNK | 0 | 500 | MG | ||||||||
| 118683326 | 11868332 | 7 | C | EBRANTIL | URAPIDIL | 1 | Oral | 150 MG, UNK | 0 | 150 | MG | CAPSULE | |||||||
| 118683326 | 11868332 | 8 | C | JUVELA N | TOCOPHERYL NICOTINATE, D-.ALPHA. | 1 | Oral | 300 MG, UNK | 0 | 300 | MG | CAPSULE | |||||||
| 118683326 | 11868332 | 9 | C | UBRETID | DISTIGMINE BROMIDE | 1 | Oral | 5 MG, UNK | 0 | 5 | MG | ||||||||
| 118683326 | 11868332 | 10 | C | BONALON | ALENDRONATE SODIUM | 1 | Oral | 3.5 MG, QW | 0 | 3.5 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118683326 | 11868332 | 1 | Multiple sclerosis |
| 118683326 | 11868332 | 5 | Prophylaxis |
| 118683326 | 11868332 | 6 | Prophylaxis |
| 118683326 | 11868332 | 7 | Prophylaxis |
| 118683326 | 11868332 | 8 | Prophylaxis |
| 118683326 | 11868332 | 9 | Prophylaxis |
| 118683326 | 11868332 | 10 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118683326 | 11868332 | HO |
| 118683326 | 11868332 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118683326 | 11868332 | Alanine aminotransferase increased | |
| 118683326 | 11868332 | Aspartate aminotransferase increased | |
| 118683326 | 11868332 | Blood alkaline phosphatase increased | |
| 118683326 | 11868332 | Decreased appetite | |
| 118683326 | 11868332 | Dysarthria | |
| 118683326 | 11868332 | Fatigue | |
| 118683326 | 11868332 | Gamma-glutamyltransferase increased | |
| 118683326 | 11868332 | Incoherent | |
| 118683326 | 11868332 | Liver disorder | |
| 118683326 | 11868332 | Lymphocyte count decreased | |
| 118683326 | 11868332 | Mental status changes | |
| 118683326 | 11868332 | Multiple sclerosis relapse | |
| 118683326 | 11868332 | Platelet count decreased | |
| 118683326 | 11868332 | Prescribed underdose | |
| 118683326 | 11868332 | Somnolence | |
| 118683326 | 11868332 | 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 |
|---|---|---|---|---|---|---|
| 118683326 | 11868332 | 1 | 20130402 | 20130414 | 0 | |
| 118683326 | 11868332 | 2 | 20130415 | 20131014 | 0 | |
| 118683326 | 11868332 | 3 | 20131015 | 20140110 | 0 | |
| 118683326 | 11868332 | 4 | 20140122 | 20140303 | 0 |