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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97037463 | 9703746 | 3 | F | 20130123 | 20160705 | 20131122 | 20160712 | PER | PHEH2013US016471 | NOVARTIS | 52.51 | YR | F | Y | 0.00000 | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97037463 | 9703746 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 11.4779997 | MG | Y | 22527 | .5 | MG | CAPSULE | QD | |||
| 97037463 | 9703746 | 2 | C | MICROGESTIN | ETHINYL ESTRADIOLNORETHINDRONE ACETATE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 97037463 | 9703746 | 3 | C | VESICARE | SOLIFENACIN SUCCINATE | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | TABLET | QD | |||||
| 97037463 | 9703746 | 4 | C | FLUTICASONE PROPIONATE. | FLUTICASONE PROPIONATE | 1 | Nasal | 2 SPRAYS IN EACH NOSTRIL | U | 0 | |||||||||
| 97037463 | 9703746 | 5 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | QD | ||||||
| 97037463 | 9703746 | 6 | C | ZOSTAVAX | VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN | 1 | Unknown | U | 0 | ||||||||||
| 97037463 | 9703746 | 7 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | 0.5 MG, TID | U | 0 | .5 | MG | TABLET | TID | |||||
| 97037463 | 9703746 | 8 | C | AMANTADINE | AMANTADINE | 1 | Unknown | U | 0 | ||||||||||
| 97037463 | 9703746 | 9 | C | ESTRACE | ESTRADIOL | 1 | Unknown | U | 0 | ||||||||||
| 97037463 | 9703746 | 10 | C | ATIVAN | LORAZEPAM | 1 | Unknown | U | 0 | ||||||||||
| 97037463 | 9703746 | 11 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | U | 0 | ||||||||||
| 97037463 | 9703746 | 12 | C | MULTI-VIT | VITAMINS | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 97037463 | 9703746 | 1 | Multiple sclerosis |
| 97037463 | 9703746 | 2 | Product used for unknown indication |
| 97037463 | 9703746 | 3 | Hypertonic bladder |
| 97037463 | 9703746 | 4 | Product used for unknown indication |
| 97037463 | 9703746 | 5 | Product used for unknown indication |
| 97037463 | 9703746 | 6 | Product used for unknown indication |
| 97037463 | 9703746 | 7 | Anxiety |
| 97037463 | 9703746 | 8 | Product used for unknown indication |
| 97037463 | 9703746 | 9 | Product used for unknown indication |
| 97037463 | 9703746 | 10 | Product used for unknown indication |
| 97037463 | 9703746 | 11 | Product used for unknown indication |
| 97037463 | 9703746 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 97037463 | 9703746 | HO |
| 97037463 | 9703746 | OT |
| 97037463 | 9703746 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 97037463 | 9703746 | Asthenia | |
| 97037463 | 9703746 | Ataxia | |
| 97037463 | 9703746 | Balance disorder | |
| 97037463 | 9703746 | Cerebellar ataxia | |
| 97037463 | 9703746 | Clumsiness | |
| 97037463 | 9703746 | Cognitive disorder | |
| 97037463 | 9703746 | Condition aggravated | |
| 97037463 | 9703746 | Coordination abnormal | |
| 97037463 | 9703746 | Diplopia | |
| 97037463 | 9703746 | Dysarthria | |
| 97037463 | 9703746 | Dysmetria | |
| 97037463 | 9703746 | Dysphagia | |
| 97037463 | 9703746 | Dysstasia | |
| 97037463 | 9703746 | Eye movement disorder | |
| 97037463 | 9703746 | Fall | |
| 97037463 | 9703746 | Gait disturbance | |
| 97037463 | 9703746 | Hypoaesthesia | |
| 97037463 | 9703746 | Multiple sclerosis relapse | |
| 97037463 | 9703746 | Muscular weakness | |
| 97037463 | 9703746 | Nystagmus | |
| 97037463 | 9703746 | Pain in extremity | |
| 97037463 | 9703746 | Pneumonia | |
| 97037463 | 9703746 | Posture abnormal | |
| 97037463 | 9703746 | Progressive multifocal leukoencephalopathy | |
| 97037463 | 9703746 | Speech disorder | |
| 97037463 | 9703746 | Tremor | |
| 97037463 | 9703746 | Vision blurred | |
| 97037463 | 9703746 | Visual acuity reduced | |
| 97037463 | 9703746 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 97037463 | 9703746 | 1 | 20130102 | 20130124 | 0 | |
| 97037463 | 9703746 | 4 | 20120910 | 0 | ||
| 97037463 | 9703746 | 5 | 20120904 | 0 |