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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111173336 | 11117333 | 6 | F | 20150416 | 20160824 | 20150515 | 20160830 | EXP | PHHY2014BR166514 | NOVARTIS | 43.13 | YR | F | Y | 57.00000 | KG | 20160830 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111173336 | 11117333 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | SA656/SC766 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 111173336 | 11117333 | 2 | C | EXODUS//ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | TABLET | QD | ||||||
| 111173336 | 11117333 | 3 | C | EXODUS//ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | 1 | 0 | TABLET | |||||||||||
| 111173336 | 11117333 | 4 | C | EXODUS//ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | 1 | 0 | TABLET | |||||||||||
| 111173336 | 11117333 | 5 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111173336 | 11117333 | 1 | Multiple sclerosis |
| 111173336 | 11117333 | 2 | Multiple sclerosis |
| 111173336 | 11117333 | 3 | Depression |
| 111173336 | 11117333 | 4 | Mood altered |
| 111173336 | 11117333 | 5 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111173336 | 11117333 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111173336 | 11117333 | Abdominal discomfort | |
| 111173336 | 11117333 | Abdominal distension | |
| 111173336 | 11117333 | Alanine aminotransferase abnormal | |
| 111173336 | 11117333 | Alanine aminotransferase increased | |
| 111173336 | 11117333 | Aspartate aminotransferase increased | |
| 111173336 | 11117333 | Back injury | |
| 111173336 | 11117333 | Central nervous system lesion | |
| 111173336 | 11117333 | Crying | |
| 111173336 | 11117333 | Dizziness | |
| 111173336 | 11117333 | Dyspnoea | |
| 111173336 | 11117333 | Eye pain | |
| 111173336 | 11117333 | Fall | |
| 111173336 | 11117333 | Fatigue | |
| 111173336 | 11117333 | Gamma-glutamyltransferase increased | |
| 111173336 | 11117333 | Headache | |
| 111173336 | 11117333 | Hypotension | |
| 111173336 | 11117333 | Influenza | |
| 111173336 | 11117333 | Irritability | |
| 111173336 | 11117333 | Mood altered | |
| 111173336 | 11117333 | Muscular weakness | |
| 111173336 | 11117333 | Musculoskeletal stiffness | |
| 111173336 | 11117333 | Paraesthesia | |
| 111173336 | 11117333 | Photophobia | |
| 111173336 | 11117333 | Tremor | |
| 111173336 | 11117333 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 111173336 | 11117333 | 1 | 201410 | 0 | ||
| 111173336 | 11117333 | 2 | 201401 | 0 | ||
| 111173336 | 11117333 | 5 | 201411 | 0 |