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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111236826 | 11123682 | 6 | F | 20140912 | 20160815 | 20150519 | 20160822 | EXP | PHHY2015US056334 | NOVARTIS | 53.89 | YR | F | Y | 56.70000 | KG | 20160822 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111236826 | 11123682 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 111236826 | 11123682 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, UNK | 22527 | .5 | MG | CAPSULE | |||||||
| 111236826 | 11123682 | 3 | C | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Oral | 100 MG, TID | 0 | 100 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111236826 | 11123682 | 1 | Multiple sclerosis |
| 111236826 | 11123682 | 3 | Trigeminal neuralgia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111236826 | 11123682 | OT |
| 111236826 | 11123682 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111236826 | 11123682 | Aphasia | |
| 111236826 | 11123682 | Ataxia | |
| 111236826 | 11123682 | Balance disorder | |
| 111236826 | 11123682 | Blood potassium decreased | |
| 111236826 | 11123682 | Bruxism | |
| 111236826 | 11123682 | Carotid arteriosclerosis | |
| 111236826 | 11123682 | Cerebral atrophy | |
| 111236826 | 11123682 | Cerebral infarction | |
| 111236826 | 11123682 | Chest discomfort | |
| 111236826 | 11123682 | Confusional state | |
| 111236826 | 11123682 | Eosinophil count increased | |
| 111236826 | 11123682 | Foaming at mouth | |
| 111236826 | 11123682 | Generalised tonic-clonic seizure | |
| 111236826 | 11123682 | Mental status changes | |
| 111236826 | 11123682 | Microvascular coronary artery disease | |
| 111236826 | 11123682 | Plantar fasciitis | |
| 111236826 | 11123682 | Sleep apnoea syndrome | |
| 111236826 | 11123682 | Speech disorder | |
| 111236826 | 11123682 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 111236826 | 11123682 | 1 | 20131107 | 0 | ||
| 111236826 | 11123682 | 2 | 20140912 | 0 | ||
| 111236826 | 11123682 | 3 | 201511 | 0 |