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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 89800835 | 8980083 | 5 | F | 201209 | 20160810 | 20121221 | 20160812 | EXP | PHHY2012AU115824 | NOVARTIS | 35.07 | YR | F | Y | 0.00000 | 20160812 | OT | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 89800835 | 8980083 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Unknown | UNK UKN, UNK | 22527 | CAPSULE | |||||||||
| 89800835 | 8980083 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Unknown | UNK | 22527 | CAPSULE | |||||||||
| 89800835 | 8980083 | 3 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | UNK UKN, UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 89800835 | 8980083 | 1 | Product used for unknown indication |
| 89800835 | 8980083 | 3 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 89800835 | 8980083 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 89800835 | 8980083 | Central nervous system lesion | |
| 89800835 | 8980083 | Cognitive disorder | |
| 89800835 | 8980083 | Expanded disability status scale score increased | |
| 89800835 | 8980083 | Facial paresis | |
| 89800835 | 8980083 | Fatigue | |
| 89800835 | 8980083 | Headache | |
| 89800835 | 8980083 | Hemiparesis | |
| 89800835 | 8980083 | Hyperreflexia | |
| 89800835 | 8980083 | Immune reconstitution inflammatory syndrome | |
| 89800835 | 8980083 | Malaise | |
| 89800835 | 8980083 | Memory impairment | |
| 89800835 | 8980083 | Monoparesis | |
| 89800835 | 8980083 | Multiple sclerosis relapse | |
| 89800835 | 8980083 | Muscular weakness | |
| 89800835 | 8980083 | Personality change | |
| 89800835 | 8980083 | Progressive multifocal leukoencephalopathy | |
| 89800835 | 8980083 | Weight 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 |
|---|---|---|---|---|---|---|
| 89800835 | 8980083 | 1 | 20120828 | 20121205 | 0 | |
| 89800835 | 8980083 | 3 | 20080703 | 20120725 | 0 |