The Safety Rates Drug Report

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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
123291883 12329188 3 F 2016 20160705 20160503 20160708 EXP US-INCYTE CORPORATION-2016IN002443 INCYTE 55.18 YR M Y 85.60000 KG 20160708 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
123291883 12329188 1 PS JAKAFI RUXOLITINIB 1 Oral 5 MG, BID U AE2923K 202192 5 MG TABLET
123291883 12329188 2 SS JAKAFI RUXOLITINIB 1 Oral 5 MG, BID U 202192 5 MG TABLET
123291883 12329188 3 SS JAKAFI RUXOLITINIB 1 Oral 2.5 MG (0.5 TABLET), BID U 202192 2.5 MG TABLET
123291883 12329188 4 SS PREDNISONE. PREDNISONE 1 10 MG 850 MG 0
123291883 12329188 5 SS PREDNISONE. PREDNISONE 1 LOW DOSE 850 MG 0
123291883 12329188 6 SS PREDNISONE. PREDNISONE 1 80 MG (1 MG/KG) 850 MG 0
123291883 12329188 7 SS PREDNISONE. PREDNISONE 1 65 MG 850 MG 0
123291883 12329188 8 SS PREDNISONE. PREDNISONE 1 Oral 55 MG, QD 850 MG 0 55 MG
123291883 12329188 9 SS PREDNISONE. PREDNISONE 1 Oral 50 MG, QD 850 MG 0 50 MG
123291883 12329188 10 SS PREDNISONE. PREDNISONE 1 40 MG, QD 850 MG 0 40 MG
123291883 12329188 11 SS PREDNISONE. PREDNISONE 1 45 MG, QD (DAILY) 850 MG 0 45 MG
123291883 12329188 12 C BACTRIM SULFAMETHOXAZOLETRIMETHOPRIM 1 0
123291883 12329188 13 C FLUCONAZOLE. FLUCONAZOLE 1 0
123291883 12329188 14 C LOVENOX ENOXAPARIN SODIUM 1 80 MG, BID 960 MG Y 0 80 MG
123291883 12329188 15 C LOVENOX ENOXAPARIN SODIUM 1 80 MG, BID 960 MG Y 0 80 MG
123291883 12329188 16 C ACYCLOVIR /00587301/ ACYCLOVIR 1 Oral 400 MG, BID (2 TIMES A DAY) 0 400 MG TABLET
123291883 12329188 17 C AZITHROMYCIN ANHYDROUS. AZITHROMYCIN ANHYDROUS 1 Oral 250 MG, QD (EVERY 24 HOURS) 0 250 MG TABLET
123291883 12329188 18 C CEFADROXIL. CEFADROXIL 1 Oral 500 MG, Q12H 0 CAPSULE
123291883 12329188 19 C PENTAMIDINE PENTAMIDINE 1 300 MG, ONCE A MONTH 0 INJECTION
123291883 12329188 20 C POSACONAZOLE POSACONAZOLE 1 Oral 3 TABLETS QD (EVERY 24 HOURS) 0 TABLET
123291883 12329188 21 C ALBUTEROL /00139501/ ALBUTEROL 1 Respiratory (inhalation) 2 PUFFS, QID (4 TIMES A DAY) 0 INHALER
123291883 12329188 22 C ALPHA LIPOIC 2 Oral 300 MG, BID (2 TIMES A DAY) 0 300 MG TABLET
123291883 12329188 23 C AMLODIPINE AMLODIPINE BESYLATE 1 Oral 10 MG, QD (EVERY 24 HOURS) Y 0 10 MG TABLET
123291883 12329188 24 C AMMONIUM LACTATE. AMMONIUM LACTATE 1 Topical 1 APPLICATION, BID (2 TIMES A DAY) 0 LOTION (EXCEPT LOTION FOR EYE)
123291883 12329188 25 C DEXAMETHASONE. DEXAMETHASONE 1 Oral 10 ML, TID (3 TIMES A DAY) 0 10 ML LIQUID
123291883 12329188 26 C LABETALOL LABETALOLLABETALOL HYDROCHLORIDE 1 Oral 400 MG, TID (3 TIMES A DAY) (Q8H) 0 400 MG
123291883 12329188 27 C LEVOTHYROXINE. LEVOTHYROXINE 1 Oral 25 MCG (0.025 MG), QD (ONCE A DAY) 0 TABLET
123291883 12329188 28 C MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL 1 TAPERED OFF 0 TABLET
123291883 12329188 29 C MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL 1 TAPERED OFF 0 TABLET
123291883 12329188 30 C MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL 1 UNK 0 TABLET
123291883 12329188 31 C MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL 1 1 G, TID 0 1 G TABLET
123291883 12329188 32 C MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL 1 Oral 1000 MG (2 TABLETS), BID (TWICE A DAY) 0 1000 MG TABLET
123291883 12329188 33 C MUPIROCIN. MUPIROCIN 1 Topical 1 APPLICATION 2 TIMES A DAY 0 OINTMENT, CREAM
123291883 12329188 34 C MUPIROCIN. MUPIROCIN 1 0 OINTMENT, CREAM
123291883 12329188 35 C OMEGA 3 /01333901/ FISH OILTOCOPHEROL 1 Oral 1200 MG Q12H (EVERY 12 HOURS) 0 CAPSULE
123291883 12329188 36 C PROTONIX /00661201/ OMEPRAZOLE 1 Oral 40 MG, QD 0 40 MG GRANULE
123291883 12329188 37 C SILVER SULFADIAZINE. SILVER SULFADIAZINE 1 Topical 1 APPLICATION Q12H (EVERY 12 HOURS) 0 CREAM
123291883 12329188 38 C HYDROMORPHONE HYDROMORPHONE 1 Oral 1 TABLET Q4H, PRN (EVERY 4 HOURS, AS NEEDED) 0 TABLET
123291883 12329188 39 C CALCIUM CARBONATE. CALCIUM CARBONATE 1 Oral 500 MG, BID (2 TIMES A DAY) 0 500 MG CHEWABLE TABLET
123291883 12329188 40 C K-TAB POTASSIUM CHLORIDE 1 Oral 20 MEQ (1 TABLET QD (ONCE A DAY)) 0 TABLET
123291883 12329188 41 C VITAMIN D2 ERGOCALCIFEROL 1 Oral 2000 IU, QD (DAILY) 0 2000 IU CAPSULE
123291883 12329188 42 C VITAMIN D2 ERGOCALCIFEROL 1 Oral 50000 IU (1.25 MG), ONCE A WEEK 0 CAPSULE

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
123291883 12329188 1 Chronic graft versus host disease
123291883 12329188 2 Mantle cell lymphoma
123291883 12329188 3 Off label use
123291883 12329188 4 Graft versus host disease
123291883 12329188 12 Product used for unknown indication
123291883 12329188 13 Product used for unknown indication
123291883 12329188 14 Product used for unknown indication
123291883 12329188 16 Antiviral prophylaxis
123291883 12329188 17 Prophylaxis
123291883 12329188 18 Prophylaxis
123291883 12329188 19 Prophylaxis
123291883 12329188 20 Antifungal prophylaxis
123291883 12329188 21 Dyspnoea
123291883 12329188 22 Neuropathy peripheral
123291883 12329188 23 Hypertension
123291883 12329188 24 Prophylaxis
123291883 12329188 25 Graft versus host disease
123291883 12329188 26 Hypertension
123291883 12329188 27 Thyroid hormone replacement therapy
123291883 12329188 28 Graft versus host disease
123291883 12329188 33 Skin ulcer
123291883 12329188 34 Wound treatment
123291883 12329188 35 Supplementation therapy
123291883 12329188 36 Prophylaxis against gastrointestinal ulcer
123291883 12329188 37 Wound treatment
123291883 12329188 38 Pain
123291883 12329188 39 Supplementation therapy
123291883 12329188 40 Supplementation therapy
123291883 12329188 41 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
123291883 12329188 HO
123291883 12329188 DE
123291883 12329188 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
123291883 12329188 Anaemia
123291883 12329188 Anal incontinence
123291883 12329188 Asthenia
123291883 12329188 Back pain
123291883 12329188 Blood immunoglobulin G decreased
123291883 12329188 Coronavirus test positive
123291883 12329188 Cough
123291883 12329188 Death
123291883 12329188 Deep vein thrombosis
123291883 12329188 Dyspnoea
123291883 12329188 Enterococcal infection
123291883 12329188 Epistaxis
123291883 12329188 Fall
123291883 12329188 Fatigue
123291883 12329188 Fractured sacrum
123291883 12329188 Hypoaesthesia
123291883 12329188 Hypoxia
123291883 12329188 Leukopenia
123291883 12329188 Medication error
123291883 12329188 Oedema peripheral
123291883 12329188 Off label use
123291883 12329188 Pancytopenia
123291883 12329188 Pneumonia
123291883 12329188 Pulmonary embolism
123291883 12329188 Scleroderma
123291883 12329188 Skin ulcer
123291883 12329188 Thrombocytopenia
123291883 12329188 Tremor
123291883 12329188 Weight decreased
123291883 12329188 White blood cell count 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
123291883 12329188 2 201603 20160427 0
123291883 12329188 3 20160427 0
123291883 12329188 4 20150325 0
123291883 12329188 5 20151106 0
123291883 12329188 6 20151106 0
123291883 12329188 7 201512 0
123291883 12329188 8 20160510 0
123291883 12329188 9 20160510 20160526 0
123291883 12329188 11 20160526 0
123291883 12329188 14 20160413 20160418 0
123291883 12329188 15 20160419 20160421 0
123291883 12329188 26 20160216 0
123291883 12329188 28 20141118 0
123291883 12329188 29 201503 0
123291883 12329188 30 20151229 0
123291883 12329188 31 20160605 0
123291883 12329188 32 20160605 0