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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118133864 | 11813386 | 4 | F | 20150817 | 20160919 | 20151209 | 20160922 | PER | PHHY2015US101348 | NOVARTIS | 50.03 | YR | M | Y | 93.20000 | KG | 20160922 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118133864 | 11813386 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 118133864 | 11813386 | 2 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | Unknown | 10 MG, PRN (AT BEDTIME) | U | 0 | 10 | MG | |||||||
| 118133864 | 11813386 | 3 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | 10 MG, TID | 0 | 10 | MG | TABLET | TID | ||||||
| 118133864 | 11813386 | 4 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 0.5 MG, TID | 0 | .5 | MG | TID | |||||||
| 118133864 | 11813386 | 5 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 0 | ||||||||||||
| 118133864 | 11813386 | 6 | C | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 118133864 | 11813386 | 7 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 300 MG, TID | 0 | 300 | MG | TID | |||||||
| 118133864 | 11813386 | 8 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | UNK | N | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118133864 | 11813386 | 1 | Multiple sclerosis |
| 118133864 | 11813386 | 2 | Product used for unknown indication |
| 118133864 | 11813386 | 3 | Muscle spasms |
| 118133864 | 11813386 | 4 | Myoclonus |
| 118133864 | 11813386 | 5 | Anxiety |
| 118133864 | 11813386 | 6 | Depression |
| 118133864 | 11813386 | 7 | Paraesthesia |
| 118133864 | 11813386 | 8 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118133864 | 11813386 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118133864 | 11813386 | Aggression | |
| 118133864 | 11813386 | Anxiety | |
| 118133864 | 11813386 | Asthenia | |
| 118133864 | 11813386 | Balance disorder | |
| 118133864 | 11813386 | Central nervous system lesion | |
| 118133864 | 11813386 | Fear | |
| 118133864 | 11813386 | Headache | |
| 118133864 | 11813386 | Hypoaesthesia | |
| 118133864 | 11813386 | Malaise | |
| 118133864 | 11813386 | Multiple sclerosis relapse | |
| 118133864 | 11813386 | Nervousness | |
| 118133864 | 11813386 | Night sweats | |
| 118133864 | 11813386 | Paraesthesia | |
| 118133864 | 11813386 | Restless legs syndrome | |
| 118133864 | 11813386 | Sinusitis | |
| 118133864 | 11813386 | Tearfulness |
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 |
|---|---|---|---|---|---|---|
| 118133864 | 11813386 | 1 | 20150812 | 0 | ||
| 118133864 | 11813386 | 3 | 201412 | 0 | ||
| 118133864 | 11813386 | 4 | 20140102 | 0 | ||
| 118133864 | 11813386 | 6 | 20150203 | 0 | ||
| 118133864 | 11813386 | 7 | 201412 | 0 | ||
| 118133864 | 11813386 | 8 | 20151112 | 20160114 | 0 |