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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117449574 | 11744957 | 4 | F | 201511 | 20160705 | 20151117 | 20160714 | PER | PHEH2015US022994 | NOVARTIS | 60.02 | YR | F | Y | 95.24000 | KG | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117449574 | 11744957 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | F0019 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 117449574 | 11744957 | 2 | C | PROVIGIL | MODAFINIL | 1 | Unknown | UNK | U | 0 | |||||||||
| 117449574 | 11744957 | 3 | C | CALCIUM | CALCIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 117449574 | 11744957 | 4 | C | ALEVE | NAPROXEN SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 117449574 | 11744957 | 5 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | UNK | U | 0 | |||||||||
| 117449574 | 11744957 | 6 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 117449574 | 11744957 | 7 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | 25 MG, UNK | U | 0 | 25 | MG | |||||||
| 117449574 | 11744957 | 8 | C | ECOTRIN | ASPIRIN | 1 | Unknown | U | 0 | ||||||||||
| 117449574 | 11744957 | 9 | C | ADVEL | 2 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117449574 | 11744957 | 1 | Multiple sclerosis |
| 117449574 | 11744957 | 2 | Sleep disorder |
| 117449574 | 11744957 | 3 | Product used for unknown indication |
| 117449574 | 11744957 | 4 | Product used for unknown indication |
| 117449574 | 11744957 | 5 | Product used for unknown indication |
| 117449574 | 11744957 | 6 | Product used for unknown indication |
| 117449574 | 11744957 | 7 | Product used for unknown indication |
| 117449574 | 11744957 | 8 | Product used for unknown indication |
| 117449574 | 11744957 | 9 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117449574 | 11744957 | Abdominal discomfort | |
| 117449574 | 11744957 | Abdominal pain upper | |
| 117449574 | 11744957 | Arthralgia | |
| 117449574 | 11744957 | Asthenia | |
| 117449574 | 11744957 | Back pain | |
| 117449574 | 11744957 | Balance disorder | |
| 117449574 | 11744957 | Blood pressure increased | |
| 117449574 | 11744957 | Body temperature increased | |
| 117449574 | 11744957 | Clumsiness | |
| 117449574 | 11744957 | Decreased appetite | |
| 117449574 | 11744957 | Depression | |
| 117449574 | 11744957 | Dyspnoea | |
| 117449574 | 11744957 | Eye disorder | |
| 117449574 | 11744957 | Fall | |
| 117449574 | 11744957 | Fatigue | |
| 117449574 | 11744957 | Flushing | |
| 117449574 | 11744957 | Headache | |
| 117449574 | 11744957 | Heart rate decreased | |
| 117449574 | 11744957 | Hypersensitivity | |
| 117449574 | 11744957 | Lymphadenopathy | |
| 117449574 | 11744957 | Myalgia | |
| 117449574 | 11744957 | Nasal congestion | |
| 117449574 | 11744957 | Nausea | |
| 117449574 | 11744957 | Pain in extremity | |
| 117449574 | 11744957 | Somnolence | |
| 117449574 | 11744957 | Swelling | |
| 117449574 | 11744957 | Thirst |
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 |
|---|---|---|---|---|---|---|
| 117449574 | 11744957 | 1 | 20151105 | 0 |