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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121955833 | 12195583 | 3 | F | 20160316 | 20160829 | 20160321 | 20160831 | PER | PHEH2016US006754 | NOVARTIS | 36.49 | YR | M | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121955833 | 12195583 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | QD | |||||||
| 121955833 | 12195583 | 2 | C | AMANTADINE | AMANTADINE | 1 | Oral | 100 MG, BID | 0 | 100 | MG | BID | |||||||
| 121955833 | 12195583 | 3 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | 500 MG, QD | 0 | 500 | MG | QD | |||||||
| 121955833 | 12195583 | 4 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | UNK | U | 0 | |||||||||
| 121955833 | 12195583 | 5 | C | MVI | VITAMINS | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121955833 | 12195583 | 1 | Multiple sclerosis |
| 121955833 | 12195583 | 2 | Fatigue |
| 121955833 | 12195583 | 3 | Herpes virus infection |
| 121955833 | 12195583 | 4 | Product used for unknown indication |
| 121955833 | 12195583 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121955833 | 12195583 | Blepharospasm | |
| 121955833 | 12195583 | Chest pain | |
| 121955833 | 12195583 | Dyspnoea | |
| 121955833 | 12195583 | Heart rate 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 |
|---|---|---|---|---|---|---|
| 121955833 | 12195583 | 1 | 20160311 | 0 |