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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
116848064 | 11684806 | 4 | F | 20160817 | 20151029 | 20160819 | EXP | PHHY2015BR138228 | NOVARTIS | 0.00 | F | Y | 64.00000 | KG | 20160819 | MD | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
116848064 | 11684806 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | SA656 | 22527 | .5 | MG | CAPSULE | QD | |||||
116848064 | 11684806 | 2 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 1 DF, QD | 0 | 1 | DF | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
116848064 | 11684806 | 1 | Multiple sclerosis |
116848064 | 11684806 | 2 | Anxiety |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
116848064 | 11684806 | OT |
116848064 | 11684806 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
116848064 | 11684806 | Abasia | |
116848064 | 11684806 | Anaemia | |
116848064 | 11684806 | Balance disorder | |
116848064 | 11684806 | Bone pain | |
116848064 | 11684806 | Dyspnoea | |
116848064 | 11684806 | Fatigue | |
116848064 | 11684806 | Feeling abnormal | |
116848064 | 11684806 | Malaise | |
116848064 | 11684806 | Memory impairment | |
116848064 | 11684806 | Menorrhagia | |
116848064 | 11684806 | Nervousness | |
116848064 | 11684806 | Pain | |
116848064 | 11684806 | Thyroid mass | |
116848064 | 11684806 | Weight decreased | |
116848064 | 11684806 | 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 |
---|---|---|---|---|---|---|
116848064 | 11684806 | 1 | 2014 | 0 |