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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127659211 | 12765921 | 1 | I | 201607 | 20160914 | 20160921 | 20160921 | EXP | PHHY2016BR128461 | NOVARTIS | 29.64 | YR | M | Y | 80.00000 | KG | 20160921 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127659211 | 12765921 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
127659211 | 12765921 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QOD | 22527 | .5 | MG | CAPSULE | |||||||
127659211 | 12765921 | 3 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
127659211 | 12765921 | 4 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | UNK | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127659211 | 12765921 | 1 | Multiple sclerosis |
127659211 | 12765921 | 4 | Multiple sclerosis relapse |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
127659211 | 12765921 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127659211 | 12765921 | Abdominal distension | |
127659211 | 12765921 | Anxiety | |
127659211 | 12765921 | Gait disturbance | |
127659211 | 12765921 | Haematemesis | |
127659211 | 12765921 | Hemiparesis | |
127659211 | 12765921 | Hiccups | |
127659211 | 12765921 | Malaise | |
127659211 | 12765921 | Multiple sclerosis relapse | |
127659211 | 12765921 | Prescribed underdose | |
127659211 | 12765921 | Vomiting |
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 |
---|---|---|---|---|---|---|
127659211 | 12765921 | 1 | 2013 | 0 | ||
127659211 | 12765921 | 2 | 2013 | 0 | ||
127659211 | 12765921 | 3 | 2013 | 0 |