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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102441087 | 10244108 | 7 | F | 20130924 | 20160919 | 20140618 | 20160921 | PER | PHHY2014US070023 | NOVARTIS | 31.76 | YR | M | Y | 109.00000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102441087 | 10244108 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 102441087 | 10244108 | 2 | C | CLONIDINE. | CLONIDINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 102441087 | 10244108 | 3 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | UNK | U | 0 | |||||||||
| 102441087 | 10244108 | 4 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Unknown | 10 MG, QD | 0 | 10 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 102441087 | 10244108 | 1 | Multiple sclerosis |
| 102441087 | 10244108 | 2 | Hypertension |
| 102441087 | 10244108 | 3 | Supplementation therapy |
| 102441087 | 10244108 | 4 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 102441087 | 10244108 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 102441087 | 10244108 | Alanine aminotransferase increased | |
| 102441087 | 10244108 | Aspartate aminotransferase increased | |
| 102441087 | 10244108 | Biliary dyskinesia | |
| 102441087 | 10244108 | Blood alkaline phosphatase increased | |
| 102441087 | 10244108 | Hypercholesterolaemia | |
| 102441087 | 10244108 | Lymphocyte count decreased | |
| 102441087 | 10244108 | Upper respiratory tract infection | |
| 102441087 | 10244108 | Urinary retention |
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 |
|---|---|---|---|---|---|---|
| 102441087 | 10244108 | 1 | 20120814 | 0 | ||
| 102441087 | 10244108 | 2 | 20130322 | 0 | ||
| 102441087 | 10244108 | 3 | 20121115 | 0 | ||
| 102441087 | 10244108 | 4 | 20121011 | 0 |