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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126191871 | 12619187 | 1 | I | 20080213 | 20090216 | 20160803 | 20160803 | EXP | JP-BIOGEN-A200900017 | BIOGEN | 38.14 | YR | F | Y | 0.00000 | 20160803 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126191871 | 12619187 | 1 | PS | AVONEX | INTERFERON BETA-1A | 1 | Intramuscular | Y | 0 | 30 | UG | SOLN FOR INJECT IN PRE-FILLED SYRINGE | /wk | ||||||
| 126191871 | 12619187 | 2 | C | TEGRETOL | CARBAMAZEPINE | 1 | Oral | 0 | 200 | MG | TABLETS | BID | |||||||
| 126191871 | 12619187 | 3 | C | GASTER | FAMOTIDINE | 1 | Oral | 0 | 20 | MG | TABLETS | BID | |||||||
| 126191871 | 12619187 | 4 | C | ALFAROL | ALFACALCIDOL | 1 | Oral | 0 | 1 | UG | CAPSULES | QD | |||||||
| 126191871 | 12619187 | 5 | C | SENNOSIDE | SENNOSIDES | 1 | Unknown | 0 | 12 | MG | TABLETS | QD | |||||||
| 126191871 | 12619187 | 6 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 0 | TABLETS | QD | |||||||||
| 126191871 | 12619187 | 7 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 1000 | MG | INJECTION | QD | |||||||
| 126191871 | 12619187 | 8 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 1000 | MG | INJECTION | QD | |||||||
| 126191871 | 12619187 | 9 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 1000 | MG | INJECTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126191871 | 12619187 | 1 | Relapsing-remitting multiple sclerosis |
| 126191871 | 12619187 | 2 | Relapsing-remitting multiple sclerosis |
| 126191871 | 12619187 | 3 | Prophylaxis |
| 126191871 | 12619187 | 4 | Prophylaxis |
| 126191871 | 12619187 | 5 | Relapsing-remitting multiple sclerosis |
| 126191871 | 12619187 | 6 | Relapsing-remitting multiple sclerosis |
| 126191871 | 12619187 | 7 | Relapsing-remitting multiple sclerosis |
| 126191871 | 12619187 | 8 | Relapsing-remitting multiple sclerosis |
| 126191871 | 12619187 | 9 | Relapsing-remitting multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126191871 | 12619187 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126191871 | 12619187 | Dysuria | |
| 126191871 | 12619187 | Hemiparesis | |
| 126191871 | 12619187 | Hypoaesthesia | |
| 126191871 | 12619187 | Multiple sclerosis relapse | |
| 126191871 | 12619187 | Sensory disturbance | |
| 126191871 | 12619187 | Visual acuity reduced | |
| 126191871 | 12619187 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 126191871 | 12619187 | 1 | 20071114 | 20080229 | 0 | |
| 126191871 | 12619187 | 2 | 2002 | 0 | ||
| 126191871 | 12619187 | 3 | 2002 | 0 | ||
| 126191871 | 12619187 | 4 | 2002 | 0 | ||
| 126191871 | 12619187 | 5 | 2006 | 0 | ||
| 126191871 | 12619187 | 6 | 20030324 | 0 | ||
| 126191871 | 12619187 | 7 | 20080213 | 20080217 | 0 | |
| 126191871 | 12619187 | 8 | 20080307 | 20080311 | 0 | |
| 126191871 | 12619187 | 9 | 20080430 | 20080504 | 0 |