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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114186958 | 11418695 | 8 | F | 20140707 | 20160816 | 20150826 | 20160822 | PER | PHHY2014US134366 | NOVARTIS | 54.52 | YR | F | Y | 55.78000 | KG | 20160822 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114186958 | 11418695 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 196.914002 | MG | Y | 22527 | .5 | MG | CAPSULE | QD | |||
| 114186958 | 11418695 | 2 | C | MAGNESIUM | MAGNESIUM | 1 | Oral | 250 MG, QD | U | 0 | 250 | MG | QD | ||||||
| 114186958 | 11418695 | 3 | C | B12-VITAMIIN | 2 | Oral | 1000 UG, QD | U | 0 | 1000 | UG | QD | |||||||
| 114186958 | 11418695 | 4 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 5000 IU, QD | U | 0 | 5000 | IU | QD | ||||||
| 114186958 | 11418695 | 5 | C | ACTONEL | RISEDRONATE SODIUM | 1 | Oral | 75 MG, QD | U | 0 | 75 | MG | QD | ||||||
| 114186958 | 11418695 | 6 | C | ACTONEL | RISEDRONATE SODIUM | 1 | Unknown | QW | U | 0 | /wk | ||||||||
| 114186958 | 11418695 | 7 | C | AMPYRA | DALFAMPRIDINE | 1 | Oral | 10 MG, BID | 20 | MG | Y | 0 | 10 | MG | BID | ||||
| 114186958 | 11418695 | 8 | C | TRAZODON | TRAZODONE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 114186958 | 11418695 | 9 | C | TRAZODON | TRAZODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 114186958 | 11418695 | 10 | C | MELATONIN | MELATONIN | 1 | Oral | 3 MG, PRN | Y | 0 | 3 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114186958 | 11418695 | 1 | Multiple sclerosis |
| 114186958 | 11418695 | 2 | Muscle spasms |
| 114186958 | 11418695 | 3 | Prophylaxis |
| 114186958 | 11418695 | 4 | Vitamin D deficiency |
| 114186958 | 11418695 | 5 | Osteoporosis |
| 114186958 | 11418695 | 7 | Gait disturbance |
| 114186958 | 11418695 | 8 | Insomnia |
| 114186958 | 11418695 | 9 | Back pain |
| 114186958 | 11418695 | 10 | Sleep disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114186958 | 11418695 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114186958 | 11418695 | Abdominal pain | |
| 114186958 | 11418695 | Alanine aminotransferase decreased | |
| 114186958 | 11418695 | Alopecia | |
| 114186958 | 11418695 | Back pain | |
| 114186958 | 11418695 | Bronchitis | |
| 114186958 | 11418695 | Concomitant disease aggravated | |
| 114186958 | 11418695 | Contusion | |
| 114186958 | 11418695 | Diarrhoea | |
| 114186958 | 11418695 | Fall | |
| 114186958 | 11418695 | Fungal infection | |
| 114186958 | 11418695 | Gait disturbance | |
| 114186958 | 11418695 | Headache | |
| 114186958 | 11418695 | Hypothyroidism | |
| 114186958 | 11418695 | Irritability | |
| 114186958 | 11418695 | Laceration | |
| 114186958 | 11418695 | Muscle strain | |
| 114186958 | 11418695 | Poor quality sleep | |
| 114186958 | 11418695 | Seasonal affective disorder | |
| 114186958 | 11418695 | Seborrhoeic keratosis | |
| 114186958 | 11418695 | Sinusitis | |
| 114186958 | 11418695 | Solar lentigo | |
| 114186958 | 11418695 | Spinal osteoarthritis | |
| 114186958 | 11418695 | Upper-airway cough syndrome | |
| 114186958 | 11418695 | Wheezing | |
| 114186958 | 11418695 | 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 |
|---|---|---|---|---|---|---|
| 114186958 | 11418695 | 1 | 20140613 | 20150930 | 0 | |
| 114186958 | 11418695 | 2 | 20140530 | 0 | ||
| 114186958 | 11418695 | 3 | 201402 | 0 | ||
| 114186958 | 11418695 | 4 | 2013 | 0 | ||
| 114186958 | 11418695 | 6 | 2012 | 0 | ||
| 114186958 | 11418695 | 7 | 20140709 | 20140709 | 0 | |
| 114186958 | 11418695 | 8 | 20160321 | 0 | ||
| 114186958 | 11418695 | 10 | 201102 | 201408 | 0 |