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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117724029 | 11772402 | 9 | F | 20150701 | 20160803 | 20151124 | 20160809 | EXP | PHHY2015FR120333 | NOVARTIS | 35.96 | YR | F | Y | 65.00000 | KG | 20160809 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117724029 | 11772402 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 55 | MG | Y | 22527 | .5 | MG | CAPSULE | QD | |||
| 117724029 | 11772402 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 55 | MG | Y | 22527 | .5 | MG | CAPSULE | QD | |||
| 117724029 | 11772402 | 3 | C | MEDROL | METHYLPREDNISOLONE | 1 | Unknown | 300 MG, QD | 1200 | MG | Y | 0 | 300 | MG | QD | ||||
| 117724029 | 11772402 | 4 | C | VESICARE | SOLIFENACIN SUCCINATE | 1 | Unknown | 5 MG, QD | 0 | 5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117724029 | 11772402 | 1 | Relapsing-remitting multiple sclerosis |
| 117724029 | 11772402 | 3 | Product used for unknown indication |
| 117724029 | 11772402 | 4 | Micturition disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117724029 | 11772402 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117724029 | 11772402 | Asthenia | |
| 117724029 | 11772402 | Autoimmune hepatitis | |
| 117724029 | 11772402 | Bronchitis | |
| 117724029 | 11772402 | Portal fibrosis |
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 |
|---|---|---|---|---|---|---|
| 117724029 | 11772402 | 1 | 20150512 | 20150703 | 0 | |
| 117724029 | 11772402 | 2 | 20150709 | 20150914 | 0 | |
| 117724029 | 11772402 | 3 | 20150717 | 20150720 | 0 | |
| 117724029 | 11772402 | 4 | 2015 | 0 |