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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120392753 | 12039275 | 3 | F | 20140217 | 20160725 | 20160208 | 20160728 | PER | PHHY2014US116195 | NOVARTIS | 49.45 | YR | F | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120392753 | 12039275 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | UNK | 22527 | CAPSULE | |||||||||
| 120392753 | 12039275 | 2 | C | MULTI VITAMIN | VITAMINS | 1 | Unknown | UNK | U | 0 | |||||||||
| 120392753 | 12039275 | 3 | C | ESTRACE | ESTRADIOL | 1 | Unknown | UNK | U | 0 | |||||||||
| 120392753 | 12039275 | 4 | C | TRILEPTAL | OXCARBAZEPINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 120392753 | 12039275 | 5 | C | PROGESTERONE. | PROGESTERONE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120392753 | 12039275 | 1 | Multiple sclerosis |
| 120392753 | 12039275 | 2 | Supplementation therapy |
| 120392753 | 12039275 | 3 | Hot flush |
| 120392753 | 12039275 | 4 | Product used for unknown indication |
| 120392753 | 12039275 | 5 | Menopause |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120392753 | 12039275 | Blood alkaline phosphatase increased | |
| 120392753 | 12039275 | Depression | |
| 120392753 | 12039275 | Dry eye | |
| 120392753 | 12039275 | Dry mouth | |
| 120392753 | 12039275 | Dyspnoea | |
| 120392753 | 12039275 | Fatigue | |
| 120392753 | 12039275 | Glossodynia | |
| 120392753 | 12039275 | Headache | |
| 120392753 | 12039275 | Hot flush | |
| 120392753 | 12039275 | Hypertension | |
| 120392753 | 12039275 | Irritability | |
| 120392753 | 12039275 | Lymphocyte count decreased | |
| 120392753 | 12039275 | Muscle tightness | |
| 120392753 | 12039275 | Neutrophil count decreased | |
| 120392753 | 12039275 | Type 2 diabetes mellitus | |
| 120392753 | 12039275 | White blood cell count 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 |
|---|---|---|---|---|---|---|
| 120392753 | 12039275 | 2 | 20150413 | 0 | ||
| 120392753 | 12039275 | 3 | 20150930 | 0 | ||
| 120392753 | 12039275 | 4 | 20150930 | 0 |