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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113193854 | 11319385 | 4 | F | 201410 | 20160919 | 20150729 | 20160923 | PER | PHEH2014US016379 | NOVARTIS | 65.60 | YR | M | Y | 99.79000 | KG | 20160923 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113193854 | 11319385 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | S0067 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 113193854 | 11319385 | 2 | C | CATAPRES | CLONIDINE HYDROCHLORIDE | 1 | Oral | 1 DF, BID | U | 0 | 1 | DF | TABLET | BID | |||||
| 113193854 | 11319385 | 3 | C | TIAZAC | DILTIAZEM HYDROCHLORIDE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | CAPSULE | QD | |||||
| 113193854 | 11319385 | 4 | C | TIAZAC | DILTIAZEM HYDROCHLORIDE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | CAPSULE | QD | |||||
| 113193854 | 11319385 | 5 | C | CARDURA | DOXAZOSIN MESYLATE | 1 | Oral | 0.5 DF, QD (BED TIME) | Y | 0 | .5 | DF | TABLET | QD | |||||
| 113193854 | 11319385 | 6 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | EXTENDED RELEASE CAPSULES | QD | |||||
| 113193854 | 11319385 | 7 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | Nasal | 2 DF, QD (2 SPRAY IN EACH NOSTRIL) | U | 0 | 2 | DF | NASAL SPRAY | QD | |||||
| 113193854 | 11319385 | 8 | C | NEURONTIN | GABAPENTIN | 1 | Oral | 1 DF, QD (BEDTIME) | U | 0 | 100 | MG | CAPSULE | QD | |||||
| 113193854 | 11319385 | 9 | C | NEURONTIN | GABAPENTIN | 1 | Oral | 1 DF, TID | U | 0 | 1 | DF | CAPSULE | TID | |||||
| 113193854 | 11319385 | 10 | C | COZAAR | LOSARTAN POTASSIUM | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 113193854 | 11319385 | 11 | C | PROVIGIL | MODAFINIL | 1 | Unknown | UNK | U | 0 | TABLET | ||||||||
| 113193854 | 11319385 | 12 | C | PROVIGIL | MODAFINIL | 1 | Oral | 100 MG, UNK | U | 0 | 100 | MG | TABLET | ||||||
| 113193854 | 11319385 | 13 | C | PRAVACHOL | PRAVASTATIN SODIUM | 1 | Oral | 1 DF, QD AT BEDTIME | U | 0 | 1 | DF | TABLET | QD | |||||
| 113193854 | 11319385 | 14 | C | ZETIA | EZETIMIBE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 113193854 | 11319385 | 15 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 1-2 TABLETS EVERY 4 HOUR, PRN | U | 0 | TABLET | ||||||||
| 113193854 | 11319385 | 16 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 1 DF, BID | U | 0 | 1 | DF | TABLET | BID | |||||
| 113193854 | 11319385 | 17 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | ENTERIC-FILM-COATED TABLET | QD | |||||
| 113193854 | 11319385 | 18 | C | TIMOLOL MALEATE. | TIMOLOL MALEATE | 1 | Unknown | 0.5 %, UNK | U | 0 | .5 | PCT | |||||||
| 113193854 | 11319385 | 19 | C | BENZONATATE. | BENZONATATE | 1 | Unknown | 100 MG, UNK | U | 0 | 100 | MG | |||||||
| 113193854 | 11319385 | 20 | C | ALENDRONATE | ALENDRONATE SODIUM | 1 | Oral | 1 DF, UNK | U | 0 | 1 | DF | |||||||
| 113193854 | 11319385 | 21 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 125 MG, UNK | Y | 0 | 125 | MG | |||||||
| 113193854 | 11319385 | 22 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 113193854 | 11319385 | 23 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | UNK | Y | 0 | |||||||||
| 113193854 | 11319385 | 24 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Oral | 1 DF, QD, 40MG | U | 0 | 1 | DF | QD | ||||||
| 113193854 | 11319385 | 25 | C | LOSARTAN. | LOSARTAN | 1 | Oral | 50 MG, UNK | U | 0 | 50 | MG | |||||||
| 113193854 | 11319385 | 26 | C | GABAPENTIN 1A PHARMA | GABAPENTIN | 1 | Oral | 1 DF, TID | U | 0 | 1 | DF | TID | ||||||
| 113193854 | 11319385 | 27 | C | DULOXETINE. | DULOXETINE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 113193854 | 11319385 | 28 | C | DOXAZOCIN | DOXAZOSIN MESYLATE | 1 | Unknown | 1 MG, UNK | U | 0 | 1 | MG | |||||||
| 113193854 | 11319385 | 29 | C | DILTIAZEM CD | DILTIAZEM | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 113193854 | 11319385 | 30 | C | ONDANSETRON | ONDANSETRON | 1 | Unknown | UNK | Y | 0 | |||||||||
| 113193854 | 11319385 | 31 | C | ONDANSETRON | ONDANSETRON | 1 | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113193854 | 11319385 | 1 | Relapsing-remitting multiple sclerosis |
| 113193854 | 11319385 | 2 | Product used for unknown indication |
| 113193854 | 11319385 | 3 | Product used for unknown indication |
| 113193854 | 11319385 | 5 | Product used for unknown indication |
| 113193854 | 11319385 | 6 | Product used for unknown indication |
| 113193854 | 11319385 | 7 | Product used for unknown indication |
| 113193854 | 11319385 | 8 | Product used for unknown indication |
| 113193854 | 11319385 | 10 | Product used for unknown indication |
| 113193854 | 11319385 | 11 | Product used for unknown indication |
| 113193854 | 11319385 | 13 | Product used for unknown indication |
| 113193854 | 11319385 | 14 | Product used for unknown indication |
| 113193854 | 11319385 | 15 | Pain |
| 113193854 | 11319385 | 16 | Product used for unknown indication |
| 113193854 | 11319385 | 17 | Product used for unknown indication |
| 113193854 | 11319385 | 18 | Product used for unknown indication |
| 113193854 | 11319385 | 19 | Product used for unknown indication |
| 113193854 | 11319385 | 20 | Product used for unknown indication |
| 113193854 | 11319385 | 21 | Multiple sclerosis relapse |
| 113193854 | 11319385 | 22 | Abdominal pain |
| 113193854 | 11319385 | 23 | Abdominal pain |
| 113193854 | 11319385 | 24 | Product used for unknown indication |
| 113193854 | 11319385 | 25 | Product used for unknown indication |
| 113193854 | 11319385 | 26 | Product used for unknown indication |
| 113193854 | 11319385 | 27 | Product used for unknown indication |
| 113193854 | 11319385 | 28 | Product used for unknown indication |
| 113193854 | 11319385 | 29 | Product used for unknown indication |
| 113193854 | 11319385 | 30 | Nausea |
| 113193854 | 11319385 | 31 | Vomiting |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113193854 | 11319385 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113193854 | 11319385 | Abasia | |
| 113193854 | 11319385 | Abdominal discomfort | |
| 113193854 | 11319385 | Dizziness | |
| 113193854 | 11319385 | Dysphagia | |
| 113193854 | 11319385 | Gait disturbance | |
| 113193854 | 11319385 | Hypertension | |
| 113193854 | 11319385 | Hypokinesia | |
| 113193854 | 11319385 | Malaise | |
| 113193854 | 11319385 | Multiple sclerosis relapse | |
| 113193854 | 11319385 | Nausea | |
| 113193854 | 11319385 | Upper respiratory tract infection | |
| 113193854 | 11319385 | Urinary tract infection | |
| 113193854 | 11319385 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 113193854 | 11319385 | 1 | 20140813 | 0 | ||
| 113193854 | 11319385 | 2 | 20140821 | 0 | ||
| 113193854 | 11319385 | 3 | 20140526 | 0 | ||
| 113193854 | 11319385 | 4 | 20140925 | 0 | ||
| 113193854 | 11319385 | 5 | 20141012 | 0 | ||
| 113193854 | 11319385 | 6 | 20140925 | 0 | ||
| 113193854 | 11319385 | 7 | 20140831 | 0 | ||
| 113193854 | 11319385 | 8 | 20141026 | 0 | ||
| 113193854 | 11319385 | 9 | 20150220 | 0 | ||
| 113193854 | 11319385 | 10 | 20141011 | 0 | ||
| 113193854 | 11319385 | 11 | 20141004 | 0 | ||
| 113193854 | 11319385 | 12 | 20150220 | 0 | ||
| 113193854 | 11319385 | 13 | 20140821 | 0 | ||
| 113193854 | 11319385 | 14 | 20141004 | 0 | ||
| 113193854 | 11319385 | 18 | 20140604 | 0 | ||
| 113193854 | 11319385 | 19 | 20130714 | 0 | ||
| 113193854 | 11319385 | 20 | 20121228 | 0 | ||
| 113193854 | 11319385 | 21 | 20141013 | 20141024 | 0 | |
| 113193854 | 11319385 | 22 | 20150114 | 20150118 | 0 | |
| 113193854 | 11319385 | 23 | 20150114 | 20150123 | 0 | |
| 113193854 | 11319385 | 24 | 20140821 | 0 | ||
| 113193854 | 11319385 | 25 | 20141011 | 0 | ||
| 113193854 | 11319385 | 26 | 20150220 | 0 | ||
| 113193854 | 11319385 | 27 | 20140925 | 0 | ||
| 113193854 | 11319385 | 28 | 20141012 | 0 | ||
| 113193854 | 11319385 | 29 | 20140925 | 0 | ||
| 113193854 | 11319385 | 30 | 20150114 | 20150121 | 0 |