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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120072912 | 12007291 | 2 | F | 20140714 | 20160926 | 20160204 | 20160929 | PER | PHEH2014US014334 | NOVARTIS | 46.54 | YR | F | Y | 51.40000 | KG | 20160929 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120072912 | 12007291 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 120072912 | 12007291 | 2 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 10 MG, UNK | U | 0 | 10 | MG | |||||||
| 120072912 | 12007291 | 3 | C | KLONOPIN | CLONAZEPAM | 1 | Oral | 1.5 DF, QD | U | 0 | 1.5 | DF | QD | ||||||
| 120072912 | 12007291 | 4 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 2 DF, QD | U | 0 | 2 | DF | QD | ||||||
| 120072912 | 12007291 | 5 | C | TYLENOL WITH CODEINE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | Oral | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120072912 | 12007291 | 1 | Multiple sclerosis |
| 120072912 | 12007291 | 2 | Muscle spasticity |
| 120072912 | 12007291 | 3 | Depression |
| 120072912 | 12007291 | 4 | Depression |
| 120072912 | 12007291 | 5 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120072912 | 12007291 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120072912 | 12007291 | Bradycardia | |
| 120072912 | 12007291 | Concomitant disease aggravated | |
| 120072912 | 12007291 | Diarrhoea | |
| 120072912 | 12007291 | Feeling abnormal | |
| 120072912 | 12007291 | Nausea | |
| 120072912 | 12007291 | Pyrexia | |
| 120072912 | 12007291 | Somnolence | |
| 120072912 | 12007291 | Upper respiratory tract infection | |
| 120072912 | 12007291 | Urinary hesitation |
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 |
|---|---|---|---|---|---|---|
| 120072912 | 12007291 | 1 | 20140714 | 0 | ||
| 120072912 | 12007291 | 2 | 20090828 | 0 | ||
| 120072912 | 12007291 | 3 | 20080502 | 0 | ||
| 120072912 | 12007291 | 4 | 20101028 | 0 | ||
| 120072912 | 12007291 | 5 | 20110506 | 0 |