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Drug     Injury     Quarter    

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
121316903 12131690 3 F 20150921 20160628 20160301 20160701 EXP US-JNJFOC-20151212074 JANSSEN 3.00 DEC A M Y 65.75000 KG 20160701 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
121316903 12131690 1 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 342.5 MG AT START U 15B083P1;15A033P1;FHM70013P1 0 5 MG/KG LYOPHILIZED POWDER
121316903 12131690 2 PS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) AT 2 INDUCTION DOSE U 15B083P1;15A033P1;FHM70013P1 103772 5 MG/KG LYOPHILIZED POWDER
121316903 12131690 3 C FOLVITE FOLIC ACID 1 Oral 0 1 MG TABLET QD
121316903 12131690 4 C ZITHROMAX AZITHROMYCIN DIHYDRATE 1 Oral TAKE 2 TABLETS FOR ONE DAY AND THEN 1 TABLET FOR NEXT 4 DAYS. 0 250 MG TABLET QD
121316903 12131690 5 C ARAVA LEFLUNOMIDE 1 Oral 0 10 MG TABLET BID
121316903 12131690 6 C METHOTREXATE. METHOTREXATE 1 Oral 8 TABLET WEEKLY 0 2.5 MG TABLET
121316903 12131690 7 C PLAQUENIL HYDROXYCHLOROQUINE SULFATE 1 Oral 0 200 MG TABLET BID
121316903 12131690 8 C VICKS DAYQUIL DEXTROMETHORPHAN HYDROBROMIDEGUAIFENESIN 1 Oral DALIY AS NEEDED 0 1 DF TABLET
121316903 12131690 9 C VICKS NYQUIL ACETAMINOPHENDEXTROMETHORPHAN HYDROBROMIDEDOXYLAMINE SUCCINATE 1 Oral ONCE AS NEEDED 0 1 DF UNSPECIFIED
121316903 12131690 10 C PROVENTIL ALBUTEROL 1 Respiratory (inhalation) AS NEEDED, 2 PUFFS BY MOUTH 4 TO 6 HOURS 0 90 UG UNSPECIFIED
121316903 12131690 11 C TYLENOL ACETAMINOPHEN 1 Oral AS NEEDED 0 325 MG TABLET
121316903 12131690 12 C TYLENOL ACETAMINOPHEN 1 Oral AS NEEDED 0 325 MG TABLET
121316903 12131690 13 C SYNTHROID LEVOTHYROXINE SODIUM 1 Oral EVERY MORNING ON EMPTY STOMACH BEFORE FOOD , AT LEAST 30 MINTUES BEFORE FOOOD. 0 75 UG TABLET QD
121316903 12131690 14 C NAPROSYN NAPROXEN 1 Oral AS NEEDED 0 500 MG TABLET QOD
121316903 12131690 15 C LITHIUM. LITHIUM 1 Oral 0 450 MG TABLET
121316903 12131690 16 C ALEVE NAPROXEN SODIUM 1 Oral AS NEEDED 0 220 MG TABLET
121316903 12131690 17 C PREDNISONE. PREDNISONE 1 Unknown 0 UNSPECIFIED
121316903 12131690 18 C HYDROXYCHLOROQUINE HYDROXYCHLOROQUINE 1 Oral 0 200 MG TABLET BID
121316903 12131690 19 C HUMIRA ADALIMUMAB 1 Unknown 0 UNSPECIFIED
121316903 12131690 20 C BENADRYL DIPHENHYDRAMINE HYDROCHLORIDE 1 Oral EVERY 4 HOURS AS NEEDED, 30-60 MINUTES PRIOR TO REMICADE 0 25 MG TABLET
121316903 12131690 21 C BENADRYL DIPHENHYDRAMINE HYDROCHLORIDE 1 Oral EVERY 4 HOURS AS NEEDED, 30-60 MINUTES PRIOR TO REMICADE 0 25 MG TABLET
121316903 12131690 22 C METHOTREXATE. METHOTREXATE 1 Subcutaneous 0.8 ML 0 2.5 MG UNSPECIFIED /wk
121316903 12131690 23 C SYNTHROID LEVOTHYROXINE SODIUM 1 Oral MORNIGN, EMPTY ATOMACH, 30 MINUTES BEFORE BREAKFAST 0 75 UG TABLET QD
121316903 12131690 24 C BENADRYL DIPHENHYDRAMINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) EVERY 4 HOURS AS NEEDED, 30-60 MINUTES PRIOR TO REMICADE 0 25 MG UNSPECIFIED
121316903 12131690 25 C BENADRYL DIPHENHYDRAMINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) EVERY 4 HOURS AS NEEDED, 30-60 MINUTES PRIOR TO REMICADE 0 25 MG UNSPECIFIED
121316903 12131690 26 C Q-PAP ACETAMINOPHEN 1 Oral 0
121316903 12131690 27 C Q-PAP ACETAMINOPHEN 1 Oral 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
121316903 12131690 1 Rheumatoid arthritis
121316903 12131690 2 Rheumatoid arthritis
121316903 12131690 5 Rheumatoid arthritis
121316903 12131690 6 Rheumatoid arthritis
121316903 12131690 10 Dyspnoea
121316903 12131690 11 Pain
121316903 12131690 12 Premedication
121316903 12131690 14 Pain
121316903 12131690 16 Pain
121316903 12131690 17 Rheumatoid arthritis
121316903 12131690 18 Rheumatoid arthritis
121316903 12131690 19 Rheumatoid arthritis
121316903 12131690 20 Pruritus
121316903 12131690 21 Premedication
121316903 12131690 22 Rheumatoid arthritis
121316903 12131690 24 Pruritus
121316903 12131690 25 Premedication
121316903 12131690 26 Premedication
121316903 12131690 27 Premedication

Outcome of event

Event ID CASEID OUTC COD
121316903 12131690 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
121316903 12131690 Abdominal pain upper
121316903 12131690 Arthralgia
121316903 12131690 Back pain
121316903 12131690 Hyperuricaemia
121316903 12131690 Infusion related reaction
121316903 12131690 Periodontal disease
121316903 12131690 Pneumonia
121316903 12131690 Rash
121316903 12131690 Respiratory disorder

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
121316903 12131690 1 20150921 0
121316903 12131690 2 20151210 0
121316903 12131690 10 20160308 0
121316903 12131690 20 20151210 0
121316903 12131690 21 20151210 0
121316903 12131690 24 20150921 0
121316903 12131690 25 20150921 0
121316903 12131690 26 20150921 0
121316903 12131690 27 20151210 0

Execution Time: 0.0081191062927246 seconds (ucode:5100878). Developed by: James D. Barger

 


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