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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118299503 | 11829950 | 3 | F | 2015 | 20160722 | 20151213 | 20160726 | PER | PHEH2015US005645 | NOVARTIS | 33.85 | YR | F | Y | 106.12000 | KG | 20160726 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118299503 | 11829950 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | S0090A, F0017 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 118299503 | 11829950 | 2 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 50000 IU, UNK | U | 0 | 50000 | IU | |||||||
| 118299503 | 11829950 | 3 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 118299503 | 11829950 | 4 | C | NAPROXEN. | NAPROXEN | 1 | Unknown | 375 MG, UNK | U | 0 | 375 | MG | |||||||
| 118299503 | 11829950 | 5 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Unknown | 20 MG, UNK | U | 0 | 20 | MG | |||||||
| 118299503 | 11829950 | 6 | C | RESTASIS | CYCLOSPORINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 118299503 | 11829950 | 7 | C | ORSYTHIA | ETHINYL ESTRADIOLLEVONORGESTREL | 1 | Unknown | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118299503 | 11829950 | 1 | Multiple sclerosis relapse |
| 118299503 | 11829950 | 2 | Product used for unknown indication |
| 118299503 | 11829950 | 3 | Product used for unknown indication |
| 118299503 | 11829950 | 4 | Product used for unknown indication |
| 118299503 | 11829950 | 5 | Product used for unknown indication |
| 118299503 | 11829950 | 6 | Product used for unknown indication |
| 118299503 | 11829950 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118299503 | 11829950 | Back pain | |
| 118299503 | 11829950 | Cough | |
| 118299503 | 11829950 | Dizziness | |
| 118299503 | 11829950 | Dyspnoea | |
| 118299503 | 11829950 | Fatigue | |
| 118299503 | 11829950 | Feeling abnormal | |
| 118299503 | 11829950 | Headache | |
| 118299503 | 11829950 | Hepatic enzyme increased | |
| 118299503 | 11829950 | Irritability | |
| 118299503 | 11829950 | Malaise | |
| 118299503 | 11829950 | Menstruation delayed |
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 |
|---|---|---|---|---|---|---|
| 118299503 | 11829950 | 1 | 20150224 | 0 |