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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117889676 | 11788967 | 6 | F | 201508 | 20160829 | 20151201 | 20160901 | EXP | PHHY2015BR044764 | NOVARTIS | 34.36 | YR | F | Y | 90.00000 | KG | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117889676 | 11788967 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | U | SC306 | 22527 | .5 | MG | CAPSULE | QD | ||||
| 117889676 | 11788967 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | U | 22527 | .5 | MG | CAPSULE | QD | |||||
| 117889676 | 11788967 | 3 | C | QUETIAPINE. | QUETIAPINE | 1 | Unknown | 300 MG, QD | U | 0 | 300 | MG | QD | ||||||
| 117889676 | 11788967 | 4 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | Unknown | 100 MG, QD | U | 0 | 100 | MG | QD | ||||||
| 117889676 | 11788967 | 5 | C | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | Unknown | 20 MG, QD | U | 0 | 20 | MG | QD | ||||||
| 117889676 | 11788967 | 6 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 20 DRP, QD | U | 0 | 20 | GTT | QD | ||||||
| 117889676 | 11788967 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 20 MG, QD | U | 0 | 20 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117889676 | 11788967 | 1 | Multiple sclerosis |
| 117889676 | 11788967 | 3 | Mood altered |
| 117889676 | 11788967 | 4 | Mood altered |
| 117889676 | 11788967 | 5 | Mood altered |
| 117889676 | 11788967 | 6 | Product used for unknown indication |
| 117889676 | 11788967 | 7 | Abdominal discomfort |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117889676 | 11788967 | OT |
| 117889676 | 11788967 | DS |
| 117889676 | 11788967 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117889676 | 11788967 | Abasia | |
| 117889676 | 11788967 | Asthenia | |
| 117889676 | 11788967 | Depression | |
| 117889676 | 11788967 | Diplegia | |
| 117889676 | 11788967 | Fall | |
| 117889676 | 11788967 | Fatigue | |
| 117889676 | 11788967 | Gait disturbance | |
| 117889676 | 11788967 | Gamma-glutamyltransferase increased | |
| 117889676 | 11788967 | Headache | |
| 117889676 | 11788967 | Hypoaesthesia | |
| 117889676 | 11788967 | Limb discomfort | |
| 117889676 | 11788967 | Malaise | |
| 117889676 | 11788967 | Multiple sclerosis relapse | |
| 117889676 | 11788967 | Muscular weakness | |
| 117889676 | 11788967 | Nephrolithiasis | |
| 117889676 | 11788967 | Pain in extremity | |
| 117889676 | 11788967 | Paraesthesia | |
| 117889676 | 11788967 | Renal pain | |
| 117889676 | 11788967 | Spinal pain | |
| 117889676 | 11788967 | Tremor | |
| 117889676 | 11788967 | Urinary tract infection | |
| 117889676 | 11788967 | Urosepsis | |
| 117889676 | 11788967 | Vision blurred |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |