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 |