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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
115339516 | 11533951 | 6 | F | 2015 | 20160825 | 20150922 | 20160907 | EXP | ES-AMGEN-ESPSP2015079117 | AMGEN | 67.00 | YR | E | F | Y | 0.00000 | 20160906 | CN | ES | ES |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
115339516 | 11533951 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | L76727 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
115339516 | 11533951 | 2 | I | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | M01666 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
115339516 | 11533951 | 3 | I | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | M32509 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
115339516 | 11533951 | 4 | I | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | N69734 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
115339516 | 11533951 | 5 | I | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, WEEKLY | N19328 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
115339516 | 11533951 | 6 | I | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Oral | 7.5 MG, WEEKLY (1 TABLET AT 2.5 MG EVERY 8 HOURS EVERY WEDNESDAY) | 0 | 7.5 | MG | /wk | |||||||
115339516 | 11533951 | 7 | C | EUTIROX | LEVOTHYROXINE SODIUM | 1 | 100 MUG, 1X/DAY (1 TABLET EVERY 24 HOURS) | 0 | TABLET | QD | |||||||||
115339516 | 11533951 | 8 | C | EUTIROX | LEVOTHYROXINE SODIUM | 1 | 100 UG, 1X/DAY (1 TABLET EVERY 24 HOURS) | 0 | 100 | UG | TABLET | ||||||||
115339516 | 11533951 | 9 | C | VALSARTAN. | VALSARTAN | 1 | 1 DF, 1X/DAY (1 TABLET EVERY 24 HOURS) | 0 | 160 | MG | TABLET | QD | |||||||
115339516 | 11533951 | 10 | C | VALSARTAN. | VALSARTAN | 1 | 1 DF, 1X/DAY (1 TABLET EVERY 24 HOURS) | 0 | 160 | MG | TABLET | QD | |||||||
115339516 | 11533951 | 11 | C | PANKREOFLAT | 2 | 1 DF, 3X/DAY (1 TABLET EVERY 8 HOURS) | 0 | 1 | DF | TABLET | TID | ||||||||
115339516 | 11533951 | 12 | C | PAROXETINE. | PAROXETINE | 1 | 20 MG, 1X/DAY (1 TABLET AT MIDDAY ) | 0 | 20 | MG | TABLET | QD | |||||||
115339516 | 11533951 | 13 | C | PAROXETINE. | PAROXETINE | 1 | 20 MG, 1X/DAY (1 TABLET AT MIDDAY ) | 0 | 20 | MG | TABLET | QD | |||||||
115339516 | 11533951 | 14 | C | ROCALTROL | CALCITRIOL | 1 | 2 DF, 1X/DAY (2 TABLETS OF 0.25 AT MIDDAY) | 0 | 2 | DF | TABLET | QD | |||||||
115339516 | 11533951 | 15 | C | NATECAL | CALCIUM CARBONATECHOLECALCIFEROL | 1 | 600 MG, UNK | 0 | 600 | MG | TABLET | ||||||||
115339516 | 11533951 | 16 | C | NATECAL | CALCIUM CARBONATECHOLECALCIFEROL | 1 | 600 MG, (2 TABS IN MORNING, 2 TABS AT MIDDAY, 1 TAB AT DINNER) | 0 | TABLET | ||||||||||
115339516 | 11533951 | 17 | C | BROMAZEPAM | BROMAZEPAM | 1 | 1 DF, 2X/DAY (1 TABLET EVERY 12 HOURS) | 0 | 1 | DF | TABLET | BID | |||||||
115339516 | 11533951 | 18 | C | BROMAZEPAM | BROMAZEPAM | 1 | 1 DF, 2X/DAY (1 TABLET EVERY 12 HOURS) | 0 | 1 | DF | TABLET | BID | |||||||
115339516 | 11533951 | 19 | C | SECALIP | FENOFIBRATE | 1 | 1 DF, 1X/DAY (1 TABLET EVERY 24 HOURS) | 0 | 1 | DF | TABLET | QD | |||||||
115339516 | 11533951 | 20 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | 5 MG, 1X/DAY (1 TABLET EVERY 24 HOURS) | 0 | 5 | MG | TABLET | QD | |||||||
115339516 | 11533951 | 21 | C | ACFOL | FOLIC ACID | 1 | 1 DF, WEEKLY (1 TABLET DAILY (EVERY THURSDAY)) | 0 | 1 | DF | TABLET | /wk | |||||||
115339516 | 11533951 | 22 | C | TRAMADOL. | TRAMADOL | 1 | 50 MG, 1X/DAY | 0 | 50 | MG | TABLET | QD | |||||||
115339516 | 11533951 | 23 | C | TRAMADOL. | TRAMADOL | 1 | 50 MG, 1X/DAY | 0 | 50 | MG | TABLET | QD | |||||||
115339516 | 11533951 | 24 | C | LANTUS | INSULIN GLARGINE | 1 | 20 IU, 1X/DAY (AT NIGHT) | 0 | 20 | IU | QD | ||||||||
115339516 | 11533951 | 25 | C | TRAMADOL RETARD | TRAMADOL | 1 | UNK, 2X/DAY | 0 | BID | ||||||||||
115339516 | 11533951 | 26 | C | ATENOLOL. | ATENOLOL | 1 | 1 DF, 1X/DAY | 0 | 1 | DF | QD | ||||||||
115339516 | 11533951 | 27 | C | ATENOLOL. | ATENOLOL | 1 | 1 DF, 1X/DAY | 0 | 1 | DF | QD | ||||||||
115339516 | 11533951 | 28 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | UNK | 0 | |||||||||||
115339516 | 11533951 | 29 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | UNK | 0 | |||||||||||
115339516 | 11533951 | 30 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | UNK | 0 | |||||||||||
115339516 | 11533951 | 31 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | UNK | 0 | |||||||||||
115339516 | 11533951 | 32 | C | CEFALIN | CEPHALEXIN | 1 | 1.45 UNK, UNK | 0 | |||||||||||
115339516 | 11533951 | 33 | C | HIDROFEROL | CALCIFEDIOL | 1 | 1 DF, MONTHLY | 0 | 1 | DF | /month | ||||||||
115339516 | 11533951 | 34 | C | QUETIAPINE. | QUETIAPINE | 1 | 25 MG, 1X/DAY | 0 | 25 | MG | QD | ||||||||
115339516 | 11533951 | 35 | C | QUETIAPINE. | QUETIAPINE | 1 | 25 MG, 1X/DAY | 0 | 25 | MG | QD | ||||||||
115339516 | 11533951 | 36 | C | EXFORGE | AMLODIPINE BESYLATEVALSARTAN | 1 | 1 TABLET, DAILY | 0 | 1 | DF | |||||||||
115339516 | 11533951 | 37 | C | EXFORGE | AMLODIPINE BESYLATEVALSARTAN | 1 | 1 TABLET, DAILY | 0 | 1 | DF | |||||||||
115339516 | 11533951 | 38 | C | TORASEMIDE | TORSEMIDE | 1 | 1/2 TABLET, DAILY | 0 | TABLET | ||||||||||
115339516 | 11533951 | 39 | C | TORASEMIDE | TORSEMIDE | 1 | 1/2 TABLET, DAILY | 0 | TABLET | ||||||||||
115339516 | 11533951 | 40 | C | SILICONE OIL | 2 | 1 SPOON EVERY 8H | 0 | 1 | DF | TID | |||||||||
115339516 | 11533951 | 41 | C | TOUJEO | INSULIN GLARGINE | 1 | 16 IU, 1X/DAY (AT NIGHT) | 0 | 16 | IU | QD | ||||||||
115339516 | 11533951 | 42 | C | TOUJEO | INSULIN GLARGINE | 1 | 14 IU, 1X/DAY (AT NIGHT) | 0 | |||||||||||
115339516 | 11533951 | 43 | C | ENTEROSILICONA | 2 | 1 SPOON EVERY 8 HOURS | 0 | 1 | DF | TID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
115339516 | 11533951 | 1 | Psoriatic arthropathy |
115339516 | 11533951 | 6 | Psoriatic arthropathy |
115339516 | 11533951 | 7 | Thyroid disorder |
115339516 | 11533951 | 9 | Hypertension |
115339516 | 11533951 | 11 | Flatulence |
115339516 | 11533951 | 12 | Depression |
115339516 | 11533951 | 14 | Vitamin D abnormal |
115339516 | 11533951 | 15 | Blood calcium abnormal |
115339516 | 11533951 | 17 | Depression |
115339516 | 11533951 | 19 | Hypercholesterolaemia |
115339516 | 11533951 | 20 | Blood triglycerides increased |
115339516 | 11533951 | 22 | Analgesic therapy |
115339516 | 11533951 | 23 | Pain |
115339516 | 11533951 | 24 | Diabetes mellitus |
115339516 | 11533951 | 25 | Analgesic therapy |
115339516 | 11533951 | 26 | Hypertension |
115339516 | 11533951 | 28 | Hypertension |
115339516 | 11533951 | 32 | Hypercholesterolaemia |
115339516 | 11533951 | 34 | Insomnia |
115339516 | 11533951 | 35 | Insomnia |
115339516 | 11533951 | 36 | Hypertension |
115339516 | 11533951 | 38 | Diuretic therapy |
115339516 | 11533951 | 40 | Flatulence |
115339516 | 11533951 | 41 | Diabetes mellitus |
115339516 | 11533951 | 43 | Flatulence |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
115339516 | 11533951 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
115339516 | 11533951 | Arthralgia | |
115339516 | 11533951 | Blood glucose abnormal | |
115339516 | 11533951 | Condition aggravated | |
115339516 | 11533951 | Disease recurrence | |
115339516 | 11533951 | Drug effect incomplete | |
115339516 | 11533951 | Drug interaction | |
115339516 | 11533951 | Dysphagia | |
115339516 | 11533951 | Fatigue | |
115339516 | 11533951 | Headache | |
115339516 | 11533951 | Hypertension | |
115339516 | 11533951 | Injection site haematoma | |
115339516 | 11533951 | Injection site haemorrhage | |
115339516 | 11533951 | Injection site mass | |
115339516 | 11533951 | Injection site urticaria | |
115339516 | 11533951 | Musculoskeletal pain | |
115339516 | 11533951 | Nasopharyngitis | |
115339516 | 11533951 | Neck pain | |
115339516 | 11533951 | Oropharyngeal pain | |
115339516 | 11533951 | Pain | |
115339516 | 11533951 | Pain in extremity | |
115339516 | 11533951 | Pharyngeal erythema | |
115339516 | 11533951 | Psoriasis | |
115339516 | 11533951 | Psoriatic arthropathy | |
115339516 | 11533951 | Rash pustular | |
115339516 | 11533951 | Somnolence | |
115339516 | 11533951 | Throat irritation | |
115339516 | 11533951 | Urticaria | |
115339516 | 11533951 | 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 |
---|---|---|---|---|---|---|
115339516 | 11533951 | 1 | 20150618 | 0 | ||
115339516 | 11533951 | 6 | 2014 | 2015 | 0 |