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
882633111 8826331 11 F 201204 20160628 20121008 20160707 EXP PHHY2012JP085203 NOVARTIS 55.67 YR M Y 57.90000 KG 20160707 MD JP JP

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
882633111 8826331 1 PS GILENYA FINGOLIMOD HYDROCHLORIDE 1 Oral 0.5 MG, QD 140 MG N 22527 .5 MG CAPSULE QD
882633111 8826331 2 SS GILENYA FINGOLIMOD HYDROCHLORIDE 1 140 MG N 22527 CAPSULE
882633111 8826331 3 SS SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE 1 Intravenous (not otherwise specified) 1000 MG, QD N 0 1000 MG INJECTION QD
882633111 8826331 4 SS SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE 1 Intravenous (not otherwise specified) 1000 MG, QD N 0 1000 MG INJECTION QD
882633111 8826331 5 C NORVASC AMLODIPINE BESYLATE 1 Oral U 0 ORAL DRUG UNSPECIFIED FORM
882633111 8826331 6 C MAGMITT KENEI 2 Oral U 0 ORAL DRUG UNSPECIFIED FORM
882633111 8826331 7 C SENNOSIDE SENNOSIDES 1 Oral U 0 ORAL DRUG UNSPECIFIED FORM
882633111 8826331 8 C KETOPROFEN. KETOPROFEN 1 Oral 20 MG, UNK U 0 20 MG
882633111 8826331 9 C ETOPOSIDE. ETOPOSIDE 1 Unknown 240 MG, UNK U 0 240 MG
882633111 8826331 10 C LENDORMIN BROTIZOLAM 1 Oral 0.25 MG, UNK U 0 .25 MG ORAL DRUG UNSPECIFIED FORM
882633111 8826331 11 C MEROPENEM. MEROPENEM 1 Unknown 0.5 MG, TID U 0 .5 MG TID
882633111 8826331 12 C AMLODIN AMLODIPINE BESYLATE 1 Oral U 0 ORAL DRUG UNSPECIFIED FORM

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
882633111 8826331 1 Secondary progressive multiple sclerosis
882633111 8826331 2 Multiple sclerosis
882633111 8826331 3 Product used for unknown indication
882633111 8826331 5 Product used for unknown indication
882633111 8826331 6 Product used for unknown indication
882633111 8826331 7 Product used for unknown indication
882633111 8826331 8 Back pain
882633111 8826331 9 Product used for unknown indication
882633111 8826331 10 Insomnia
882633111 8826331 11 Product used for unknown indication
882633111 8826331 12 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
882633111 8826331 LT
882633111 8826331 DE
882633111 8826331 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
882633111 8826331 Abdominal distension
882633111 8826331 Acquired diaphragmatic eventration
882633111 8826331 Activated partial thromboplastin time prolonged
882633111 8826331 Acute hepatic failure
882633111 8826331 Acute kidney injury
882633111 8826331 Alanine aminotransferase increased
882633111 8826331 Antithrombin III decreased
882633111 8826331 Anuria
882633111 8826331 Ascites
882633111 8826331 Aspartate aminotransferase increased
882633111 8826331 Atelectasis
882633111 8826331 Atrophy
882633111 8826331 Bilirubin conjugated increased
882633111 8826331 Blood albumin decreased
882633111 8826331 Blood alkaline phosphatase increased
882633111 8826331 Blood bicarbonate decreased
882633111 8826331 Blood bilirubin increased
882633111 8826331 Blood chloride increased
882633111 8826331 Blood creatine phosphokinase increased
882633111 8826331 Blood culture positive
882633111 8826331 Blood fibrinogen decreased
882633111 8826331 Blood lactate dehydrogenase increased
882633111 8826331 Blood phosphorus decreased
882633111 8826331 Blood potassium increased
882633111 8826331 Blood pressure abnormal
882633111 8826331 Blood urea increased
882633111 8826331 Bone marrow myelogram abnormal
882633111 8826331 C-reactive protein increased
882633111 8826331 Central nervous system lesion
882633111 8826331 Chills
882633111 8826331 Coagulation factor decreased
882633111 8826331 Constipation
882633111 8826331 Cytomegalovirus test positive
882633111 8826331 Depressed level of consciousness
882633111 8826331 Disseminated intravascular coagulation
882633111 8826331 Dyspnoea
882633111 8826331 Enterobacter test positive
882633111 8826331 Enterocolitis
882633111 8826331 Epstein-Barr virus test positive
882633111 8826331 Erythropoiesis abnormal
882633111 8826331 Escherichia test positive
882633111 8826331 Fibrin degradation products increased
882633111 8826331 Gait disturbance
882633111 8826331 Gallbladder disorder
882633111 8826331 Gamma-glutamyltransferase increased
882633111 8826331 Gastrointestinal haemorrhage
882633111 8826331 Gastrointestinal oedema
882633111 8826331 Haematemesis
882633111 8826331 Haemophilus test positive
882633111 8826331 Heart rate increased
882633111 8826331 Hepatic cyst
882633111 8826331 Hepatomegaly
882633111 8826331 Herpes simplex
882633111 8826331 Histiocytosis haematophagic
882633111 8826331 Hyperlactacidaemia
882633111 8826331 Hyperthermia
882633111 8826331 Hypoaesthesia
882633111 8826331 Insomnia
882633111 8826331 Interleukin-2 receptor increased
882633111 8826331 Lymphocyte count decreased
882633111 8826331 Lymphohistiocytosis
882633111 8826331 Malaise
882633111 8826331 Megakaryocytes decreased
882633111 8826331 Melaena
882633111 8826331 Movement disorder
882633111 8826331 Muscle rigidity
882633111 8826331 Muscular weakness
882633111 8826331 Neutrophil count increased
882633111 8826331 Nystagmus
882633111 8826331 Ocular icterus
882633111 8826331 Oropharyngeal pain
882633111 8826331 Oxygen saturation decreased
882633111 8826331 Pain
882633111 8826331 Pharyngeal oedema
882633111 8826331 Pharyngitis
882633111 8826331 Platelet count decreased
882633111 8826331 Pleural effusion
882633111 8826331 Protein total decreased
882633111 8826331 Prothrombin time prolonged
882633111 8826331 Pyrexia
882633111 8826331 Renal cyst
882633111 8826331 Respiratory disorder
882633111 8826331 Respiratory fatigue
882633111 8826331 Respiratory rate increased
882633111 8826331 Sepsis
882633111 8826331 Serum ferritin increased
882633111 8826331 Splenomegaly
882633111 8826331 Subcutaneous emphysema
882633111 8826331 Tonsillar hypertrophy
882633111 8826331 Tonsillitis
882633111 8826331 Urinary incontinence
882633111 8826331 Urinary retention
882633111 8826331 Viraemia
882633111 8826331 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
882633111 8826331 1 20111215 20120919 0
882633111 8826331 3 20120916 0
882633111 8826331 4 20120922 20120924 0
882633111 8826331 9 20120926 20120926 0
882633111 8826331 11 20120927 0