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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122850144 | 12285014 | 4 | F | 2009 | 20160824 | 20160420 | 20160831 | EXP | US-UCBSA-2016013307 | UCB | 50.91 | YR | F | Y | 54.00000 | KG | 20160831 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122850144 | 12285014 | 1 | PS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 400 MG, EV 4 WEEKS | Y | NDC NO: 50474071079 | 125160 | 400 | MG | SOLUTION FOR INJECTION | |||||
| 122850144 | 12285014 | 2 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 400 MG, EV 3 WEEKS | Y | 125160 | 400 | MG | SOLUTION FOR INJECTION | Q3W | |||||
| 122850144 | 12285014 | 3 | C | DYAZIDE | HYDROCHLOROTHIAZIDETRIAMTERENE | 1 | Oral | 37.5 MG, ONCE DAILY (QD) | U | 0 | 37.5 | MG | TABLET | QD | |||||
| 122850144 | 12285014 | 4 | C | ARMOUR THYROID | THYROID, PORCINE | 1 | Oral | 45MG DAILY (15 MG TABLETS 2 IN AM AND 1 IN PM)45 | U | 0 | BID | ||||||||
| 122850144 | 12285014 | 5 | C | XANAX | ALPRAZOLAM | 1 | Oral | 0.25MG 1 PRN OR 2 HS PRN, AS NEEDED (PRN) | U | 0 | |||||||||
| 122850144 | 12285014 | 6 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | 1 DF (5/325 MG TABLET), AS NEEDED (PRN) | U | 0 | 1 | DF | TABLET | ||||||
| 122850144 | 12285014 | 7 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | TABLET | ||||||||||
| 122850144 | 12285014 | 8 | C | KCL | POTASSIUM CHLORIDE | 1 | Oral | 20 MEQ, ONCE DAILY (QD) | U | 0 | 20 | MEQ | TABLET | QD | |||||
| 122850144 | 12285014 | 9 | C | Iron | IRON | 1 | UNK | U | 0 | ||||||||||
| 122850144 | 12285014 | 10 | C | Iron | IRON | 1 | UNK | U | 0 | INFUSION | |||||||||
| 122850144 | 12285014 | 11 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | INFUSION | |||||||||
| 122850144 | 12285014 | 12 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | ||||||||||
| 122850144 | 12285014 | 13 | C | TIROSINT | LEVOTHYROXINE SODIUM | 1 | U | 0 | |||||||||||
| 122850144 | 12285014 | 14 | C | TRIAMTERENE. | TRIAMTERENE | 1 | UNK | U | 0 | ||||||||||
| 122850144 | 12285014 | 15 | C | TRIAMTERENE. | TRIAMTERENE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122850144 | 12285014 | 1 | Crohn's disease |
| 122850144 | 12285014 | 3 | Hypertension |
| 122850144 | 12285014 | 4 | Thyroid disorder |
| 122850144 | 12285014 | 5 | Anxiety |
| 122850144 | 12285014 | 6 | Pain |
| 122850144 | 12285014 | 7 | Fibromyalgia |
| 122850144 | 12285014 | 8 | Product used for unknown indication |
| 122850144 | 12285014 | 9 | Product used for unknown indication |
| 122850144 | 12285014 | 10 | Product used for unknown indication |
| 122850144 | 12285014 | 11 | Nausea |
| 122850144 | 12285014 | 12 | Thyroid disorder |
| 122850144 | 12285014 | 13 | Thyroid disorder |
| 122850144 | 12285014 | 14 | Blood pressure fluctuation |
| 122850144 | 12285014 | 15 | Fluid retention |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122850144 | 12285014 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122850144 | 12285014 | Adenomyosis | |
| 122850144 | 12285014 | Alopecia | |
| 122850144 | 12285014 | Anaemia | |
| 122850144 | 12285014 | Antinuclear antibody positive | |
| 122850144 | 12285014 | Anxiety | |
| 122850144 | 12285014 | Arthralgia | |
| 122850144 | 12285014 | Autoimmune thyroiditis | |
| 122850144 | 12285014 | Butterfly rash | |
| 122850144 | 12285014 | Cardiac murmur | |
| 122850144 | 12285014 | Cardiovascular disorder | |
| 122850144 | 12285014 | Crohn's disease | |
| 122850144 | 12285014 | Dental caries | |
| 122850144 | 12285014 | Diarrhoea | |
| 122850144 | 12285014 | Drug eruption | |
| 122850144 | 12285014 | Drug ineffective | |
| 122850144 | 12285014 | Dry skin | |
| 122850144 | 12285014 | Fatigue | |
| 122850144 | 12285014 | Feeling abnormal | |
| 122850144 | 12285014 | Headache | |
| 122850144 | 12285014 | Hyperglycaemia | |
| 122850144 | 12285014 | Hypoglycaemia | |
| 122850144 | 12285014 | Influenza like illness | |
| 122850144 | 12285014 | Insomnia | |
| 122850144 | 12285014 | Menstrual disorder | |
| 122850144 | 12285014 | Nausea | |
| 122850144 | 12285014 | Neuropathy peripheral | |
| 122850144 | 12285014 | Oedema peripheral | |
| 122850144 | 12285014 | Off label use | |
| 122850144 | 12285014 | Rash macular | |
| 122850144 | 12285014 | Raynaud's phenomenon | |
| 122850144 | 12285014 | Solar lentigo | |
| 122850144 | 12285014 | Swelling | |
| 122850144 | 12285014 | Thinking abnormal | |
| 122850144 | 12285014 | Uterine leiomyoma | |
| 122850144 | 12285014 | 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 |
|---|---|---|---|---|---|---|
| 122850144 | 12285014 | 1 | 20090723 | 0 | ||
| 122850144 | 12285014 | 2 | 20151223 | 20160314 | 0 | |
| 122850144 | 12285014 | 4 | 2015 | 0 | ||
| 122850144 | 12285014 | 5 | 201409 | 0 | ||
| 122850144 | 12285014 | 6 | 2009 | 0 | ||
| 122850144 | 12285014 | 8 | 201509 | 0 | ||
| 122850144 | 12285014 | 12 | 201501 | 0 |