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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113988447 | 11398844 | 7 | F | 2016 | 20160901 | 20150820 | 20160908 | PER | PHEH2015US012738 | NOVARTIS | 54.53 | YR | F | Y | 65.76000 | KG | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113988447 | 11398844 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | U | 22527 | .5 | MG | CAPSULE | QD | ||||
| 113988447 | 11398844 | 2 | SS | AMPYRA | DALFAMPRIDINE | 1 | Oral | 10 MG, BID | 0 | 10 | MG | TABLET | BID | ||||||
| 113988447 | 11398844 | 3 | SS | KEFLEX | CEPHALEXIN | 1 | Unknown | UNK | 0 | ||||||||||
| 113988447 | 11398844 | 4 | C | DYAZIDE | HYDROCHLOROTHIAZIDETRIAMTERENE | 1 | Unknown | U | 0 | ||||||||||
| 113988447 | 11398844 | 5 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 7 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 8 | C | NEURONTIN | GABAPENTIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 9 | C | NITRAPAM | 2 | Unknown | UNK | U | 0 | ||||||||||
| 113988447 | 11398844 | 10 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 11 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 12 | C | PROBIOTIC//BIFIDOBACTERIUM LACTIS | 2 | Unknown | UNK | U | 0 | ||||||||||
| 113988447 | 11398844 | 13 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 14 | C | ALEVE | NAPROXEN SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 15 | C | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 16 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 17 | C | CRANBERRY//VACCINIUM MACROCARPON | CRANBERRY | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 18 | C | CALCIUM | CALCIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 19 | C | FLAXSEED | FLAX SEED | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 20 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 21 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 22 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 23 | C | MELATONIN | MELATONIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 24 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 25 | C | SMOOTH LAX | POLYETHYLENE GLYCOL 3350 | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 26 | C | TRENTAL | PENTOXIFYLLINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 27 | C | TRIAMTERENE AND HYDROCHLOROTHIZIDE | HYDROCHLOROTHIAZIDETRIAMTERENE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 28 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 29 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 30 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 31 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 32 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 33 | C | TECFIDERA | DIMETHYL FUMARATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113988447 | 11398844 | 34 | C | MVI//VITAMINS NOS | 2 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113988447 | 11398844 | 1 | Multiple sclerosis |
| 113988447 | 11398844 | 2 | Gait disturbance |
| 113988447 | 11398844 | 3 | Infection |
| 113988447 | 11398844 | 4 | Hypertension |
| 113988447 | 11398844 | 5 | Product used for unknown indication |
| 113988447 | 11398844 | 6 | Product used for unknown indication |
| 113988447 | 11398844 | 7 | Product used for unknown indication |
| 113988447 | 11398844 | 8 | Product used for unknown indication |
| 113988447 | 11398844 | 9 | Product used for unknown indication |
| 113988447 | 11398844 | 10 | Product used for unknown indication |
| 113988447 | 11398844 | 11 | Product used for unknown indication |
| 113988447 | 11398844 | 12 | Product used for unknown indication |
| 113988447 | 11398844 | 13 | Product used for unknown indication |
| 113988447 | 11398844 | 14 | Product used for unknown indication |
| 113988447 | 11398844 | 15 | Product used for unknown indication |
| 113988447 | 11398844 | 16 | Product used for unknown indication |
| 113988447 | 11398844 | 17 | Product used for unknown indication |
| 113988447 | 11398844 | 18 | Product used for unknown indication |
| 113988447 | 11398844 | 19 | Product used for unknown indication |
| 113988447 | 11398844 | 20 | Product used for unknown indication |
| 113988447 | 11398844 | 21 | Product used for unknown indication |
| 113988447 | 11398844 | 22 | Product used for unknown indication |
| 113988447 | 11398844 | 23 | Product used for unknown indication |
| 113988447 | 11398844 | 24 | Product used for unknown indication |
| 113988447 | 11398844 | 25 | Product used for unknown indication |
| 113988447 | 11398844 | 26 | Product used for unknown indication |
| 113988447 | 11398844 | 27 | Product used for unknown indication |
| 113988447 | 11398844 | 28 | Product used for unknown indication |
| 113988447 | 11398844 | 29 | Product used for unknown indication |
| 113988447 | 11398844 | 30 | Product used for unknown indication |
| 113988447 | 11398844 | 31 | Product used for unknown indication |
| 113988447 | 11398844 | 32 | Product used for unknown indication |
| 113988447 | 11398844 | 33 | Product used for unknown indication |
| 113988447 | 11398844 | 34 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113988447 | 11398844 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113988447 | 11398844 | Abdominal discomfort | |
| 113988447 | 11398844 | Aggression | |
| 113988447 | 11398844 | Asthenia | |
| 113988447 | 11398844 | Dizziness | |
| 113988447 | 11398844 | Eye pain | |
| 113988447 | 11398844 | Fatigue | |
| 113988447 | 11398844 | Headache | |
| 113988447 | 11398844 | Irritability | |
| 113988447 | 11398844 | Localised infection | |
| 113988447 | 11398844 | Lung infection | |
| 113988447 | 11398844 | Lymphocyte count decreased | |
| 113988447 | 11398844 | Nasal congestion | |
| 113988447 | 11398844 | Pain | |
| 113988447 | 11398844 | Pharyngitis | |
| 113988447 | 11398844 | Sinusitis | |
| 113988447 | 11398844 | Somnolence | |
| 113988447 | 11398844 | Viral infection | |
| 113988447 | 11398844 | 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 |
|---|---|---|---|---|---|---|
| 113988447 | 11398844 | 1 | 20150629 | 0 |