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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
916454022 9164540 22 F 20130218 20160627 20130315 20160704 EXP PHHY2013CA016965 NOVARTIS 53.89 YR F Y 0.00000 20160704 CN COUNTRY NOT SPECIFIED CA

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
916454022 9164540 1 PS TASIGNA NILOTINIB 1 Oral 300 MG, QD 22068 300 MG CAPSULE QD
916454022 9164540 2 SS TASIGNA NILOTINIB 1 Oral 150 MG, QD 22068 150 MG CAPSULE QD
916454022 9164540 3 SS TASIGNA NILOTINIB 1 Oral 150 MG QAM (EVERY DAY BEFORE NOON) AND 200 MG QHS (EVERY NIGHT AT BEDTIME) 22068 350 MG CAPSULE QD
916454022 9164540 4 SS TASIGNA NILOTINIB 1 Oral 300 MG, (IN THE EVENING) 22068 300 MG CAPSULE
916454022 9164540 5 SS TASIGNA NILOTINIB 1 Oral 150 MG IN THE MORNING 22068 150 MG CAPSULE
916454022 9164540 6 SS TASIGNA NILOTINIB 1 Oral 300 MG, BID 22068 300 MG CAPSULE BID
916454022 9164540 7 SS TASIGNA NILOTINIB 1 Oral 150 MG, BID 22068 150 MG CAPSULE BID
916454022 9164540 8 SS TASIGNA NILOTINIB 1 Oral 150 MG, QD 22068 150 MG CAPSULE QD
916454022 9164540 9 SS TASIGNA NILOTINIB 1 Oral 300 MG, QHS ((EVERY NIGHT AT BEDTIME) 22068 300 MG CAPSULE
916454022 9164540 10 SS TASIGNA NILOTINIB 1 Oral 300 MG, QD 22068 300 MG CAPSULE QD
916454022 9164540 11 SS TASIGNA NILOTINIB 1 Oral 350 MG/DAY (200 MG MORNING AND 150 MG EVENING) 22068 350 MG CAPSULE
916454022 9164540 12 SS TASIGNA NILOTINIB 1 Oral 200 MG, BID 22068 200 MG CAPSULE BID
916454022 9164540 13 SS TASIGNA NILOTINIB 1 Oral 350 MG, QD 22068 350 MG CAPSULE QD
916454022 9164540 14 SS TASIGNA NILOTINIB 1 Oral 300 MG, QD 22068 300 MG CAPSULE QD
916454022 9164540 15 SS TASIGNA NILOTINIB 1 Oral 150MG QAM AND 200MG QHS 22068 350 MG CAPSULE QD
916454022 9164540 16 SS TASIGNA NILOTINIB 1 Oral 400 MG, QD 22068 400 MG CAPSULE QD
916454022 9164540 17 SS TASIGNA NILOTINIB 1 Oral 200MG IN MORNING AND 150MG AT NIGHT 22068 350 MG CAPSULE QD
916454022 9164540 18 SS TASIGNA NILOTINIB 1 Oral 350 MG, QD (150 MG QAM AND 200 MG QPM) 22068 350 MG CAPSULE QD
916454022 9164540 19 SS TASIGNA NILOTINIB 1 Oral 200 MG, BID 22068 200 MG CAPSULE BID
916454022 9164540 20 C VITAMIN B VITAMIN B 1 Unknown U 0
916454022 9164540 21 C SYNTHROID LEVOTHYROXINE SODIUM 1 Unknown 0.75 UG, QD 0 .75 UG QD
916454022 9164540 22 C SYNTHROID LEVOTHYROXINE SODIUM 1 0.88 UG, UNK 0 .88 UG

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
916454022 9164540 1 Chronic myeloid leukaemia
916454022 9164540 20 Product used for unknown indication
916454022 9164540 21 Hypothyroidism

Outcome of event

Event ID CASEID OUTC COD
916454022 9164540 HO
916454022 9164540 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
916454022 9164540 Abdominal distension
916454022 9164540 Acne
916454022 9164540 Alopecia
916454022 9164540 Anaemia
916454022 9164540 Angioedema
916454022 9164540 Anxiety
916454022 9164540 Asthenia
916454022 9164540 Back pain
916454022 9164540 Bone loss
916454022 9164540 Confusional state
916454022 9164540 Constipation
916454022 9164540 Contusion
916454022 9164540 Convalescent
916454022 9164540 Crying
916454022 9164540 Decreased appetite
916454022 9164540 Depression
916454022 9164540 Diarrhoea
916454022 9164540 Disorientation
916454022 9164540 Disturbance in attention
916454022 9164540 Drug withdrawal syndrome
916454022 9164540 Dry eye
916454022 9164540 Dry skin
916454022 9164540 Dyspnoea
916454022 9164540 Emotional disorder
916454022 9164540 Eye swelling
916454022 9164540 Feeling abnormal
916454022 9164540 Flatulence
916454022 9164540 Gait disturbance
916454022 9164540 Gamma-glutamyltransferase increased
916454022 9164540 Gingival bleeding
916454022 9164540 Gingival pain
916454022 9164540 Hair disorder
916454022 9164540 Headache
916454022 9164540 Heart rate increased
916454022 9164540 Hepatic enzyme increased
916454022 9164540 Hypoaesthesia
916454022 9164540 Hypopnoea
916454022 9164540 Hypothyroidism
916454022 9164540 Intervertebral disc protrusion
916454022 9164540 Joint stiffness
916454022 9164540 Lid sulcus deepened
916454022 9164540 Ligament sprain
916454022 9164540 Liver disorder
916454022 9164540 Memory impairment
916454022 9164540 Muscle spasms
916454022 9164540 Muscle tightness
916454022 9164540 Musculoskeletal pain
916454022 9164540 Myalgia
916454022 9164540 Osteopenia
916454022 9164540 Pain in extremity
916454022 9164540 Pancreatic enzymes increased
916454022 9164540 Peripheral coldness
916454022 9164540 Peripheral nerve lesion
916454022 9164540 Photosensitivity reaction
916454022 9164540 Pruritus
916454022 9164540 Rash
916454022 9164540 Rash macular
916454022 9164540 Sciatica
916454022 9164540 Sedation
916454022 9164540 Skin disorder
916454022 9164540 Sunburn
916454022 9164540 Swelling face
916454022 9164540 Therapeutic response decreased
916454022 9164540 Tooth disorder
916454022 9164540 Toothache
916454022 9164540 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
916454022 9164540 3 20130216 0
916454022 9164540 4 20130217 0
916454022 9164540 5 20130218 0
916454022 9164540 6 20130222 0
916454022 9164540 7 20130226 0
916454022 9164540 10 20130415 0
916454022 9164540 11 20130503 20130827 0
916454022 9164540 12 20130921 0
916454022 9164540 13 20141127 0
916454022 9164540 14 20141128 0
916454022 9164540 15 20141129 0
916454022 9164540 16 20141205 0
916454022 9164540 17 20141215 0

Execution Time: 0.0071771144866943 seconds (ucode:5044528). Developed by: James D. Barger

 


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