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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114921004 | 11492100 | 4 | F | 201503 | 20160913 | 20150910 | 20160920 | EXP | PHHY2015CA109206 | NOVARTIS | 28.20 | YR | F | Y | 0.00000 | 20160920 | CN | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114921004 | 11492100 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | 22527 | .5 | MG | CAPSULE | QD | |||||
| 114921004 | 11492100 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Unknown | UNK | U | 0 | |||||||||
| 114921004 | 11492100 | 3 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | U | 0 | ||||||||||
| 114921004 | 11492100 | 4 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | U | 0 | ||||||||||
| 114921004 | 11492100 | 5 | C | OXYBUTYNIN | OXYBUTYNIN | 1 | Unknown | U | 0 | ||||||||||
| 114921004 | 11492100 | 6 | C | PREGABALIN. | PREGABALIN | 1 | Unknown | U | 0 | ||||||||||
| 114921004 | 11492100 | 7 | C | RANITIDINE. | RANITIDINE | 1 | Unknown | U | 0 | ||||||||||
| 114921004 | 11492100 | 8 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114921004 | 11492100 | 1 | Relapsing-remitting multiple sclerosis |
| 114921004 | 11492100 | 2 | Relapsing-remitting multiple sclerosis |
| 114921004 | 11492100 | 3 | Product used for unknown indication |
| 114921004 | 11492100 | 4 | Product used for unknown indication |
| 114921004 | 11492100 | 5 | Product used for unknown indication |
| 114921004 | 11492100 | 6 | Product used for unknown indication |
| 114921004 | 11492100 | 7 | Product used for unknown indication |
| 114921004 | 11492100 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114921004 | 11492100 | OT |
| 114921004 | 11492100 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114921004 | 11492100 | Encephalitis autoimmune | |
| 114921004 | 11492100 | Lymphopenia | |
| 114921004 | 11492100 | Postictal state | |
| 114921004 | 11492100 | Progressive multifocal leukoencephalopathy | |
| 114921004 | 11492100 | Status epilepticus | |
| 114921004 | 11492100 | Substance abuse |
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 |
|---|---|---|---|---|---|---|
| 114921004 | 11492100 | 1 | 20130926 | 20150318 | 0 | |
| 114921004 | 11492100 | 2 | 201512 | 0 |