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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124477062 | 12447706 | 2 | F | 20160607 | 20160812 | 20160608 | 20160818 | PER | PHEH2016US013960 | NOVARTIS | 59.54 | YR | F | Y | 100.30000 | KG | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124477062 | 12447706 | 1 | PS | EXTAVIA | INTERFERON BETA-1B | 1 | Subcutaneous | 0.25 MG, QOD (1 ML) | 125290 | .25 | MG | SOLUTION FOR INJECTION | |||||||
| 124477062 | 12447706 | 2 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Oral | 100 MG, QD NIGHTLY BEDTIME | U | 0 | 100 | MG | TABLET | QD | |||||
| 124477062 | 12447706 | 3 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Oral | 50 MG, QD NIGHTLY BEDTIME | U | 0 | 50 | MG | TABLET | QD | |||||
| 124477062 | 12447706 | 4 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | 1 MG, 2 TABLE (NIGHTLY BEDTIME). 2 TABLET AT NIGHT AND 1 TABLET AT AM | U | N | 0 | 1 | MG | TABLET | |||||
| 124477062 | 12447706 | 5 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 30 MG, QD | U | 0 | 30 | MG | SLOW RELEASE CAPSULES | QD | |||||
| 124477062 | 12447706 | 6 | C | LIDODERM | LIDOCAINE | 1 | Topical | 1 DF, QD | U | 0 | 1 | DF | PATCH | QD | |||||
| 124477062 | 12447706 | 7 | C | LIDODERM | LIDOCAINE | 1 | Topical | 1-2 DF, PRN | U | 0 | PATCH | ||||||||
| 124477062 | 12447706 | 8 | C | LYRICA | PREGABALIN | 1 | Oral | 300 MG, BID | U | 0 | 300 | MG | CAPSULE | BID | |||||
| 124477062 | 12447706 | 9 | C | MELOXICAM. | MELOXICAM | 1 | Oral | 15 MG, QD | U | 0 | 15 | MG | TABLET | QD | |||||
| 124477062 | 12447706 | 10 | C | NEURONTIN | GABAPENTIN | 1 | Oral | 1200 MG, BID (TID-QA FOR 30 DAYS) | 0 | 1200 | MG | TABLET | BID | ||||||
| 124477062 | 12447706 | 11 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 40 MG, QD FOR 30 DAYS | 0 | 40 | MG | CAPSULE | QD | ||||||
| 124477062 | 12447706 | 12 | C | TRAMADOL. | TRAMADOL | 1 | Oral | 100 MG, PRN (EVERY 8 HOUR) | U | 0 | 100 | MG | TABLET | ||||||
| 124477062 | 12447706 | 13 | C | VERAPAMIL | VERAPAMIL HYDROCHLORIDE | 1 | Oral | 180 MG, QD (EVERY AM) | U | 0 | 180 | MG | EXTENDED RELEASE TABLET | QD | |||||
| 124477062 | 12447706 | 14 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | Topical | 1 DF, QID (500 GM) | U | 0 | 1 | DF | GEL | QID | |||||
| 124477062 | 12447706 | 15 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 10 MG, BID FOR 30 DAYS | U | 0 | 10 | MG | TABLET | BID | |||||
| 124477062 | 12447706 | 16 | C | BUTORPHANOL | BUTORPHANOL | 1 | Nasal | 10 MG/ML, QD FOR 30 DAYS | U | 0 | NASAL SPRAY | QD | |||||||
| 124477062 | 12447706 | 17 | C | IBUPROFEN. | IBUPROFEN | 1 | Oral | 800 MG, TID (PRN) | U | 0 | 800 | MG | TABLET | TID | |||||
| 124477062 | 12447706 | 18 | C | MULTIPLE VITAMINS | VITAMINS | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 124477062 | 12447706 | 19 | C | ESTRADIOL. | ESTRADIOL | 1 | Oral | 1 MG, QD | U | 0 | 1 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124477062 | 12447706 | 1 | Relapsing-remitting multiple sclerosis |
| 124477062 | 12447706 | 2 | Product used for unknown indication |
| 124477062 | 12447706 | 4 | Product used for unknown indication |
| 124477062 | 12447706 | 5 | Product used for unknown indication |
| 124477062 | 12447706 | 6 | Product used for unknown indication |
| 124477062 | 12447706 | 8 | Product used for unknown indication |
| 124477062 | 12447706 | 9 | Product used for unknown indication |
| 124477062 | 12447706 | 10 | Product used for unknown indication |
| 124477062 | 12447706 | 11 | Product used for unknown indication |
| 124477062 | 12447706 | 12 | Product used for unknown indication |
| 124477062 | 12447706 | 13 | Product used for unknown indication |
| 124477062 | 12447706 | 14 | Product used for unknown indication |
| 124477062 | 12447706 | 15 | Product used for unknown indication |
| 124477062 | 12447706 | 16 | Migraine |
| 124477062 | 12447706 | 17 | Pain |
| 124477062 | 12447706 | 18 | Product used for unknown indication |
| 124477062 | 12447706 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124477062 | 12447706 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124477062 | 12447706 | Amnesia | |
| 124477062 | 12447706 | Anxiety | |
| 124477062 | 12447706 | Arthralgia | |
| 124477062 | 12447706 | Back pain | |
| 124477062 | 12447706 | Balance disorder | |
| 124477062 | 12447706 | Blood pressure decreased | |
| 124477062 | 12447706 | Deafness | |
| 124477062 | 12447706 | Dizziness | |
| 124477062 | 12447706 | Dysphagia | |
| 124477062 | 12447706 | Fatigue | |
| 124477062 | 12447706 | Fibromyalgia | |
| 124477062 | 12447706 | Gait disturbance | |
| 124477062 | 12447706 | Headache | |
| 124477062 | 12447706 | Hypoaesthesia | |
| 124477062 | 12447706 | Micturition urgency | |
| 124477062 | 12447706 | Multiple sclerosis | |
| 124477062 | 12447706 | Muscle spasms | |
| 124477062 | 12447706 | Muscular weakness | |
| 124477062 | 12447706 | Myalgia | |
| 124477062 | 12447706 | Neck pain | |
| 124477062 | 12447706 | Neurogenic bladder | |
| 124477062 | 12447706 | Optic nerve disorder | |
| 124477062 | 12447706 | Pain in extremity | |
| 124477062 | 12447706 | Peripheral coldness | |
| 124477062 | 12447706 | Sensory disturbance | |
| 124477062 | 12447706 | Stress urinary incontinence | |
| 124477062 | 12447706 | Temperature intolerance | |
| 124477062 | 12447706 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 124477062 | 12447706 | 1 | 19931115 | 0 |