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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124830592 | 12483059 | 2 | F | 20140309 | 20160816 | 20160620 | 20160819 | EXP | PHHY2014US045158 | NOVARTIS | 30.48 | YR | F | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124830592 | 12483059 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 347.997009 | MG | Y | 22527 | .5 | MG | CAPSULE | QD | |||
| 124830592 | 12483059 | 2 | SS | AMPYRA | DALFAMPRIDINE | 1 | Oral | 10 MG, Q12H | 13120 | MG | Y | 0 | 10 | MG | Q12H | ||||
| 124830592 | 12483059 | 3 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Oral | 100 MG, QD | 67700 | MG | 0 | 100 | MG | QD | |||||
| 124830592 | 12483059 | 4 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Oral | 50 MG, QD | 67700 | MG | 0 | 50 | MG | QD | |||||
| 124830592 | 12483059 | 5 | C | VISTARIL | HYDROXYZINE PAMOATE | 1 | Oral | 25 MG, QID | 73300 | MG | Y | 0 | 25 | MG | QID | ||||
| 124830592 | 12483059 | 6 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 10 MG, QID | U | 0 | 10 | MG | QID | ||||||
| 124830592 | 12483059 | 7 | C | ZYPREXA | OLANZAPINE | 1 | Oral | 5 MG, UNK | Y | 0 | 5 | MG | |||||||
| 124830592 | 12483059 | 8 | C | REMERON | MIRTAZAPINE | 1 | Oral | 15 MG, AT BED TIME | Y | 0 | 15 | MG | |||||||
| 124830592 | 12483059 | 9 | C | BUTALBITAL/APAP | 2 | Oral | 50 MG, QID | U | 0 | 50 | MG | QID | |||||||
| 124830592 | 12483059 | 10 | C | BUTALBITAL/APAP | 2 | Oral | 325 MG, QID | U | 0 | 325 | MG | QID | |||||||
| 124830592 | 12483059 | 11 | C | NAPROXEN. | NAPROXEN | 1 | Oral | 500 MG, PRN | U | 0 | 500 | MG | |||||||
| 124830592 | 12483059 | 12 | C | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | U | 0 | ||||||||||
| 124830592 | 12483059 | 13 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 10 MG, TID | 21990 | MG | Y | 0 | 10 | MG | TID | ||||
| 124830592 | 12483059 | 14 | C | FLEXON | ACETAMINOPHENIBUPROFEN | 1 | Oral | 10 MG, TID | U | 0 | 10 | MG | TID | ||||||
| 124830592 | 12483059 | 15 | C | FLEXON | ACETAMINOPHENIBUPROFEN | 1 | Oral | 10 MG, PRN | U | 0 | 10 | MG | |||||||
| 124830592 | 12483059 | 16 | C | ALAVERT ALLERGY | LORATADINE | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | QD | ||||||
| 124830592 | 12483059 | 17 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Oral | 75 MG, QD | 29400 | MG | Y | 0 | 75 | MG | QD | ||||
| 124830592 | 12483059 | 18 | C | MULTI-VIT | VITAMINS | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 124830592 | 12483059 | 19 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 1000 IU, QD | U | 0 | 1000 | IU | QD | ||||||
| 124830592 | 12483059 | 20 | C | MODAFINIL. | MODAFINIL | 1 | Oral | 100 MG, QD | U | 0 | 100 | MG | QD | ||||||
| 124830592 | 12483059 | 21 | C | LEVAQUIN | LEVOFLOXACIN | 1 | Oral | 500 MG, QD | Y | 0 | 500 | MG | QD | ||||||
| 124830592 | 12483059 | 22 | C | OXYBUTIN | OXYBUTYNIN | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | QD | ||||||
| 124830592 | 12483059 | 23 | C | HEPARIN | HEPARIN SODIUM | 1 | Unknown | Y | 0 | ||||||||||
| 124830592 | 12483059 | 24 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | 1 MG, PRN | 161 | MG | Y | 0 | 1 | MG | |||||
| 124830592 | 12483059 | 25 | C | PEPCID | FAMOTIDINE | 1 | Unknown | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124830592 | 12483059 | 1 | Multiple sclerosis |
| 124830592 | 12483059 | 2 | Muscle spasticity |
| 124830592 | 12483059 | 3 | Suicidal ideation |
| 124830592 | 12483059 | 4 | Depression |
| 124830592 | 12483059 | 5 | Anxiety |
| 124830592 | 12483059 | 6 | Muscle spasticity |
| 124830592 | 12483059 | 7 | Depression |
| 124830592 | 12483059 | 8 | Depression |
| 124830592 | 12483059 | 9 | Migraine |
| 124830592 | 12483059 | 11 | Pain |
| 124830592 | 12483059 | 12 | Contraception |
| 124830592 | 12483059 | 13 | Depression |
| 124830592 | 12483059 | 14 | Muscle spasticity |
| 124830592 | 12483059 | 16 | Seasonal allergy |
| 124830592 | 12483059 | 17 | Depression |
| 124830592 | 12483059 | 18 | Nutritional supplementation |
| 124830592 | 12483059 | 19 | Vitamin D deficiency |
| 124830592 | 12483059 | 20 | Fatigue |
| 124830592 | 12483059 | 21 | Urinary tract infection |
| 124830592 | 12483059 | 22 | Neurogenic bladder |
| 124830592 | 12483059 | 23 | Thrombosis prophylaxis |
| 124830592 | 12483059 | 24 | Anxiety |
| 124830592 | 12483059 | 25 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124830592 | 12483059 | HO |
| 124830592 | 12483059 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124830592 | 12483059 | Anion gap increased | |
| 124830592 | 12483059 | Basophil count decreased | |
| 124830592 | 12483059 | Blood alkaline phosphatase increased | |
| 124830592 | 12483059 | Blood calcium increased | |
| 124830592 | 12483059 | Blood creatinine increased | |
| 124830592 | 12483059 | Blood glucose increased | |
| 124830592 | 12483059 | Blood immunoglobulin G increased | |
| 124830592 | 12483059 | Carbon dioxide decreased | |
| 124830592 | 12483059 | Dehydration | |
| 124830592 | 12483059 | Eosinophil count decreased | |
| 124830592 | 12483059 | Eosinophilia | |
| 124830592 | 12483059 | Generalised tonic-clonic seizure | |
| 124830592 | 12483059 | Hyperkalaemia | |
| 124830592 | 12483059 | Hypernatraemia | |
| 124830592 | 12483059 | Hyponatraemia | |
| 124830592 | 12483059 | Hypotension | |
| 124830592 | 12483059 | Leukopenia | |
| 124830592 | 12483059 | Lymphocytosis | |
| 124830592 | 12483059 | Lymphopenia | |
| 124830592 | 12483059 | Mean cell haemoglobin increased | |
| 124830592 | 12483059 | Mean cell volume increased | |
| 124830592 | 12483059 | Monocyte count increased | |
| 124830592 | 12483059 | Neutropenia | |
| 124830592 | 12483059 | Neutrophilia | |
| 124830592 | 12483059 | Red blood cell count decreased | |
| 124830592 | 12483059 | Urinary tract infection | |
| 124830592 | 12483059 | Weight 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 |
|---|---|---|---|---|---|---|
| 124830592 | 12483059 | 1 | 20120416 | 20140313 | 0 | |
| 124830592 | 12483059 | 2 | 20120523 | 20140311 | 0 | |
| 124830592 | 12483059 | 3 | 20101026 | 20120901 | 0 | |
| 124830592 | 12483059 | 4 | 20140201 | 0 | ||
| 124830592 | 12483059 | 5 | 201009 | 20120901 | 0 | |
| 124830592 | 12483059 | 6 | 20100907 | 0 | ||
| 124830592 | 12483059 | 7 | 201011 | 20120901 | 0 | |
| 124830592 | 12483059 | 8 | 201011 | 20120901 | 0 | |
| 124830592 | 12483059 | 9 | 201009 | 0 | ||
| 124830592 | 12483059 | 11 | 201008 | 0 | ||
| 124830592 | 12483059 | 12 | 2010 | 0 | ||
| 124830592 | 12483059 | 13 | 201009 | 20120901 | 0 | |
| 124830592 | 12483059 | 14 | 20121002 | 0 | ||
| 124830592 | 12483059 | 15 | 20121002 | 0 | ||
| 124830592 | 12483059 | 16 | 20121002 | 0 | ||
| 124830592 | 12483059 | 17 | 20130105 | 20140201 | 0 | |
| 124830592 | 12483059 | 18 | 20131101 | 0 | ||
| 124830592 | 12483059 | 19 | 20131113 | 0 | ||
| 124830592 | 12483059 | 20 | 20131113 | 0 | ||
| 124830592 | 12483059 | 21 | 20140314 | 20140316 | 0 | |
| 124830592 | 12483059 | 22 | 20131111 | 0 | ||
| 124830592 | 12483059 | 23 | 20140309 | 20140314 | 0 | |
| 124830592 | 12483059 | 24 | 20130606 | 20131113 | 0 | |
| 124830592 | 12483059 | 25 | 20140309 | 20140314 | 0 |