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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 78466722 | 7846672 | 2 | F | 20080213 | 20130916 | 20110308 | 20130930 | EXP | PHHO2008JP02578 | NOVARTIS | 54.63 | YR | F | Y | 45.00000 | KG | 20130930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 78466722 | 7846672 | 1 | PS | FTY | 1 | ORAL | 1.25 MG, QD | 98 | MG | D | 22527 | 1.25 | MG | CAPSULE | QD | ||||
| 78466722 | 7846672 | 2 | C | ROHYPNOL | 1 | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 78466722 | 7846672 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 78466722 | 7846672 | OT |
| 78466722 | 7846672 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 78466722 | 7846672 | Anxiety | |
| 78466722 | 7846672 | Aphasia | |
| 78466722 | 7846672 | Back pain | |
| 78466722 | 7846672 | Bradycardia | |
| 78466722 | 7846672 | Central nervous system lesion | |
| 78466722 | 7846672 | Chest discomfort | |
| 78466722 | 7846672 | Decreased appetite | |
| 78466722 | 7846672 | Gallbladder polyp | |
| 78466722 | 7846672 | Heart rate decreased | |
| 78466722 | 7846672 | Hepatic function abnormal | |
| 78466722 | 7846672 | Malaise | |
| 78466722 | 7846672 | Motor dysfunction | |
| 78466722 | 7846672 | Multiple sclerosis | |
| 78466722 | 7846672 | Muscle fatigue | |
| 78466722 | 7846672 | Muscle tightness | |
| 78466722 | 7846672 | Muscular weakness | |
| 78466722 | 7846672 | Nausea | |
| 78466722 | 7846672 | Nervous system disorder | |
| 78466722 | 7846672 | Pain | |
| 78466722 | 7846672 | Pyrexia | |
| 78466722 | 7846672 | Restlessness | |
| 78466722 | 7846672 | Sensory disturbance | |
| 78466722 | 7846672 | Sensory loss |
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 |
|---|---|---|---|---|---|---|
| 78466722 | 7846672 | 1 | 20080213 | 20080501 | 0 |