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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113605862 | 11360586 | 2 | F | 20111028 | 20160831 | 20150810 | 20160902 | EXP | PHHY2011CA96046 | NOVARTIS | 58.09 | YR | F | Y | 0.00000 | 20160902 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113605862 | 11360586 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 113605862 | 11360586 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, DAILY | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 113605862 | 11360586 | 3 | SS | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 37.5 MG, QD | U | 0 | 37.5 | MG | QD | ||||||
| 113605862 | 11360586 | 4 | C | PHENOBARBITAL. | PHENOBARBITAL | 1 | Unknown | 90 MG, QD | Y | 0 | 90 | MG | QD | ||||||
| 113605862 | 11360586 | 5 | C | CALCIUM CARBONATE W/COLECALCIFEROL | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Unknown | UNK, BID | Y | 0 | BID | ||||||||
| 113605862 | 11360586 | 6 | C | DETROL | TOLTERODINE TARTRATE | 1 | Unknown | 1 MG, QD | Y | 0 | 1 | MG | QD | ||||||
| 113605862 | 11360586 | 7 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 0.075 MG, DAILY | Y | 0 | .075 | MG | |||||||
| 113605862 | 11360586 | 8 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 113605862 | 11360586 | 9 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Unknown | 10 MG, BID, PRN | Y | 0 | 10 | MG | BID | ||||||
| 113605862 | 11360586 | 10 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 1 DF, QHS | Y | 0 | 1 | DF | |||||||
| 113605862 | 11360586 | 11 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | 10 MG, BID/TID | Y | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113605862 | 11360586 | 1 | Relapsing-remitting multiple sclerosis |
| 113605862 | 11360586 | 3 | Depression |
| 113605862 | 11360586 | 4 | Product used for unknown indication |
| 113605862 | 11360586 | 5 | Product used for unknown indication |
| 113605862 | 11360586 | 6 | Product used for unknown indication |
| 113605862 | 11360586 | 7 | Product used for unknown indication |
| 113605862 | 11360586 | 8 | Product used for unknown indication |
| 113605862 | 11360586 | 9 | Product used for unknown indication |
| 113605862 | 11360586 | 10 | Product used for unknown indication |
| 113605862 | 11360586 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113605862 | 11360586 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113605862 | 11360586 | Abnormal behaviour | |
| 113605862 | 11360586 | Anxiety | |
| 113605862 | 11360586 | Asthenia | |
| 113605862 | 11360586 | Atrioventricular block first degree | |
| 113605862 | 11360586 | Balance disorder | |
| 113605862 | 11360586 | Crying | |
| 113605862 | 11360586 | Decreased interest | |
| 113605862 | 11360586 | Depression | |
| 113605862 | 11360586 | Disturbance in attention | |
| 113605862 | 11360586 | Expanded disability status scale score increased | |
| 113605862 | 11360586 | Fatigue | |
| 113605862 | 11360586 | Gait disturbance | |
| 113605862 | 11360586 | Heart rate decreased | |
| 113605862 | 11360586 | Hypertension | |
| 113605862 | 11360586 | Insomnia | |
| 113605862 | 11360586 | Limb discomfort | |
| 113605862 | 11360586 | Malaise | |
| 113605862 | 11360586 | Multiple sclerosis relapse | |
| 113605862 | 11360586 | Nausea | |
| 113605862 | 11360586 | Neuralgia | |
| 113605862 | 11360586 | Peripheral swelling | |
| 113605862 | 11360586 | Sleep disorder |
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 |
|---|---|---|---|---|---|---|
| 113605862 | 11360586 | 1 | 20111028 | 0 | ||
| 113605862 | 11360586 | 2 | 20111102 | 0 | ||
| 113605862 | 11360586 | 3 | 20140510 | 0 |