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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120591093 | 12059109 | 3 | F | 20160627 | 20160210 | 20160706 | EXP | PHEH2016US002947 | NOVARTIS | 0.00 | M | Y | 78.00000 | KG | 20160706 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120591093 | 12059109 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | 22527 | .5 | MG | CAPSULE | QD | |||||
| 120591093 | 12059109 | 2 | C | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 300 MG, TID | 0 | 300 | MG | TABLET | TID | ||||||
| 120591093 | 12059109 | 3 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 300 MG, TID | 0 | 300 | MG | TID | |||||||
| 120591093 | 12059109 | 4 | C | LIDODERM | LIDOCAINE | 1 | Unknown | (UPTO 12 HRS) | U | 0 | PATCH |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120591093 | 12059109 | 1 | Multiple sclerosis |
| 120591093 | 12059109 | 2 | Product used for unknown indication |
| 120591093 | 12059109 | 3 | Product used for unknown indication |
| 120591093 | 12059109 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120591093 | 12059109 | HO |
| 120591093 | 12059109 | LT |
| 120591093 | 12059109 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120591093 | 12059109 | Anaemia | |
| 120591093 | 12059109 | Apparent death | |
| 120591093 | 12059109 | Blindness | |
| 120591093 | 12059109 | Burning sensation | |
| 120591093 | 12059109 | Contusion | |
| 120591093 | 12059109 | Crying | |
| 120591093 | 12059109 | Drug ineffective | |
| 120591093 | 12059109 | Drug intolerance | |
| 120591093 | 12059109 | Dysphagia | |
| 120591093 | 12059109 | Eating disorder | |
| 120591093 | 12059109 | Facial pain | |
| 120591093 | 12059109 | Feeling abnormal | |
| 120591093 | 12059109 | Headache | |
| 120591093 | 12059109 | Insomnia | |
| 120591093 | 12059109 | Loss of consciousness | |
| 120591093 | 12059109 | Lymphocyte count decreased | |
| 120591093 | 12059109 | Malaise | |
| 120591093 | 12059109 | Multiple sclerosis relapse | |
| 120591093 | 12059109 | Nerve injury | |
| 120591093 | 12059109 | Neuralgia | |
| 120591093 | 12059109 | Paraesthesia | |
| 120591093 | 12059109 | Photophobia | |
| 120591093 | 12059109 | Rash | |
| 120591093 | 12059109 | Speech disorder | |
| 120591093 | 12059109 | Trigeminal neuralgia | |
| 120591093 | 12059109 | 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 |
|---|---|---|---|---|---|---|
| 120591093 | 12059109 | 1 | 20150929 | 201512 | 0 |