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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100809084 | 10080908 | 4 | F | 201311 | 20151222 | 20140416 | 20151231 | EXP | PT-INFARMED-L201403-210 | PHHY2014PT044315 | NOVARTIS | 30.45 | YR | M | Y | 65.00000 | KG | 20160101 | PH | PT | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100809084 | 10080908 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | S0052 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 100809084 | 10080908 | 2 | C | LIORESAL | BACLOFEN | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 100809084 | 10080908 | 3 | C | LIORESAL | BACLOFEN | 1 | Oral | 10 MG, TID | DESCONHECIDO | 0 | 10 | MG | TABLET | TID | |||||
| 100809084 | 10080908 | 4 | C | LIORESAL | BACLOFEN | 1 | Oral | 35 MG, TID | 0 | 35 | MG | TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100809084 | 10080908 | 1 | Multiple sclerosis |
| 100809084 | 10080908 | 2 | Muscle spasticity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100809084 | 10080908 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100809084 | 10080908 | Depression | |
| 100809084 | 10080908 | Expanded disability status scale score increased | |
| 100809084 | 10080908 | Gamma-glutamyltransferase increased | |
| 100809084 | 10080908 | Hepatic enzyme increased | |
| 100809084 | 10080908 | Insomnia | |
| 100809084 | 10080908 | Muscle spasticity |
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 |
|---|---|---|---|---|---|---|
| 100809084 | 10080908 | 1 | 20130315 | 0 | ||
| 100809084 | 10080908 | 2 | 2008 | 0 | ||
| 100809084 | 10080908 | 3 | 2009 | 0 | ||
| 100809084 | 10080908 | 4 | 201402 | 0 |