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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113278004 | 11327800 | 4 | F | 20130415 | 20160919 | 20150731 | 20160922 | PER | PHHY2015US042632 | NOVARTIS | 60.73 | YR | F | Y | 0.00000 | 20160922 | MD | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113278004 | 11327800 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | UNK UNK, QD | 22527 | CAPSULE | QD | ||||||||
| 113278004 | 11327800 | 2 | C | AMINOPHYLLINE. | AMINOPHYLLINE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 113278004 | 11327800 | 3 | C | AMINOPHYLLINE. | AMINOPHYLLINE | 1 | Y | 0 | |||||||||||
| 113278004 | 11327800 | 4 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | UNK | Y | 0 | |||||||||
| 113278004 | 11327800 | 5 | C | REGADENOSON | REGADENOSON | 1 | Unknown | UNK | Y | 0 | |||||||||
| 113278004 | 11327800 | 6 | C | SALINE | SODIUM CHLORIDE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 113278004 | 11327800 | 7 | C | PREMARIN | ESTROGENS, CONJUGATED | 1 | Oral | 0.625 MG, QD | U | 0 | .625 | MG | QD | ||||||
| 113278004 | 11327800 | 8 | C | TRICOR | FENOFIBRATE | 1 | Oral | 145 MG, QHS | U | 0 | 145 | MG | |||||||
| 113278004 | 11327800 | 9 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 137 UG, QD | U | 0 | 137 | UG | QD | ||||||
| 113278004 | 11327800 | 10 | C | ROBAXIN | METHOCARBAMOL | 1 | Oral | 1000 MG, PRN | U | 0 | 1000 | MG | |||||||
| 113278004 | 11327800 | 11 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Oral | 100 MG, QD | U | 0 | 100 | MG | QD | ||||||
| 113278004 | 11327800 | 12 | C | DESYREL | TRAZODONE HYDROCHLORIDE | 1 | Oral | 50 MG, QHS | U | 0 | 50 | MG | |||||||
| 113278004 | 11327800 | 13 | C | LOTREL | AMLODIPINE BESYLATEBENAZEPRIL HYDROCHLORIDE | 1 | Oral | 1 DF, QHS | U | 0 | 1 | DF | |||||||
| 113278004 | 11327800 | 14 | C | AMPYRA | DALFAMPRIDINE | 1 | Unknown | U | 0 | ||||||||||
| 113278004 | 11327800 | 15 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | U | 0 | ||||||||||
| 113278004 | 11327800 | 16 | C | TRAZODON | TRAZODONE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 113278004 | 11327800 | 17 | C | BENAZEPRIL | BENAZEPRIL HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 113278004 | 11327800 | 18 | C | METHOCARBAMOL. | METHOCARBAMOL | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113278004 | 11327800 | 1 | Multiple sclerosis |
| 113278004 | 11327800 | 2 | Stress |
| 113278004 | 11327800 | 3 | Chest pain |
| 113278004 | 11327800 | 4 | Musculoskeletal chest pain |
| 113278004 | 11327800 | 5 | Cardiac stress test |
| 113278004 | 11327800 | 6 | Cardiac stress test |
| 113278004 | 11327800 | 7 | Product used for unknown indication |
| 113278004 | 11327800 | 8 | Product used for unknown indication |
| 113278004 | 11327800 | 9 | Product used for unknown indication |
| 113278004 | 11327800 | 10 | Product used for unknown indication |
| 113278004 | 11327800 | 11 | Product used for unknown indication |
| 113278004 | 11327800 | 12 | Product used for unknown indication |
| 113278004 | 11327800 | 13 | Product used for unknown indication |
| 113278004 | 11327800 | 14 | Product used for unknown indication |
| 113278004 | 11327800 | 15 | Product used for unknown indication |
| 113278004 | 11327800 | 16 | Product used for unknown indication |
| 113278004 | 11327800 | 17 | Product used for unknown indication |
| 113278004 | 11327800 | 18 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113278004 | 11327800 | Diarrhoea | |
| 113278004 | 11327800 | Flushing | |
| 113278004 | 11327800 | Lymphocyte count decreased | |
| 113278004 | 11327800 | Multiple sclerosis relapse | |
| 113278004 | 11327800 | Pruritus |
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 |
|---|---|---|---|---|---|---|
| 113278004 | 11327800 | 2 | 20140626 | 20140626 | 0 | |
| 113278004 | 11327800 | 4 | 20140625 | 20140625 | 0 | |
| 113278004 | 11327800 | 5 | 20140626 | 20140626 | 0 | |
| 113278004 | 11327800 | 6 | 20140626 | 20140626 | 0 |