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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122240787 | 12224078 | 7 | F | 2015 | 20160808 | 20160330 | 20160811 | EXP | PHHY2015BR036844 | NOVARTIS | 33.89 | YR | F | Y | 68.00000 | KG | 20160811 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122240787 | 12224078 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD (28 CAPSULES) | Y | SA658, SC338 | 22527 | .5 | MG | CAPSULE | QD | ||||
| 122240787 | 12224078 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | 22527 | .5 | MG | CAPSULE | QD | |||||
| 122240787 | 12224078 | 3 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QOD | Y | 22527 | .5 | MG | CAPSULE | ||||||
| 122240787 | 12224078 | 4 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | 22527 | .5 | MG | CAPSULE | QD | |||||
| 122240787 | 12224078 | 5 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QOD | Y | 22527 | .5 | MG | CAPSULE | ||||||
| 122240787 | 12224078 | 6 | SS | METHADONE | METHADONE HYDROCHLORIDE | 1 | Oral | 10 MG, Q8H | U | 0 | 10 | MG | TABLET | Q8H | |||||
| 122240787 | 12224078 | 7 | SS | NEURAL | LAMOTRIGINE | 1 | Unknown | U | 0 | ||||||||||
| 122240787 | 12224078 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 20 MG, QD (MORE THAN ONE YEAR) | 0 | 20 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122240787 | 12224078 | 1 | Multiple sclerosis |
| 122240787 | 12224078 | 6 | Pain in extremity |
| 122240787 | 12224078 | 7 | Pain in extremity |
| 122240787 | 12224078 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122240787 | 12224078 | OT |
| 122240787 | 12224078 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122240787 | 12224078 | Decreased appetite | |
| 122240787 | 12224078 | Hepatic enzyme increased | |
| 122240787 | 12224078 | Infection | |
| 122240787 | 12224078 | Influenza | |
| 122240787 | 12224078 | Insomnia | |
| 122240787 | 12224078 | Liver disorder | |
| 122240787 | 12224078 | Malaise | |
| 122240787 | 12224078 | Maternal exposure during pregnancy | |
| 122240787 | 12224078 | Mobility decreased | |
| 122240787 | 12224078 | Muscular weakness | |
| 122240787 | 12224078 | Nasopharyngitis | |
| 122240787 | 12224078 | Oropharyngeal pain | |
| 122240787 | 12224078 | Pain in extremity | |
| 122240787 | 12224078 | Prescribed underdose | |
| 122240787 | 12224078 | Retching | |
| 122240787 | 12224078 | Somnolence | |
| 122240787 | 12224078 | Tremor | |
| 122240787 | 12224078 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 122240787 | 12224078 | 1 | 20150318 | 201512 | 0 | |
| 122240787 | 12224078 | 2 | 20151226 | 0 | ||
| 122240787 | 12224078 | 4 | 20160315 | 0 | ||
| 122240787 | 12224078 | 5 | 201604 | 0 |