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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111382376 | 11138237 | 6 | F | 2014 | 20160829 | 20150526 | 20160907 | EXP | PHHY2015BR037815 | NOVARTIS | 36.92 | YR | F | Y | 52.00000 | KG | 20160907 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111382376 | 11138237 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | SA244 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 111382376 | 11138237 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | SA352 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 111382376 | 11138237 | 3 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 111382376 | 11138237 | 4 | SS | MICROVLAR | ETHINYL ESTRADIOLLEVONORGESTREL | 1 | Oral | 1 DF, QD | Y | 0 | 1 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111382376 | 11138237 | 1 | Relapsing-remitting multiple sclerosis |
| 111382376 | 11138237 | 4 | Contraception |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111382376 | 11138237 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111382376 | 11138237 | Feeling abnormal | |
| 111382376 | 11138237 | Heart rate decreased | |
| 111382376 | 11138237 | Malaise | |
| 111382376 | 11138237 | Maternal exposure during pregnancy | |
| 111382376 | 11138237 | Premature delivery | |
| 111382376 | 11138237 | 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 |
|---|---|---|---|---|---|---|
| 111382376 | 11138237 | 1 | 2014 | 0 | ||
| 111382376 | 11138237 | 2 | 201511 | 0 | ||
| 111382376 | 11138237 | 3 | 20160826 | 0 | ||
| 111382376 | 11138237 | 4 | 1995 | 201510 | 0 |