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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124091124 | 12409112 | 4 | F | 20160418 | 20160915 | 20160526 | 20160925 | EXP | PHHY2016DE071155 | SANDOZ | 45.00 | YR | M | Y | 99.00000 | KG | 20160926 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124091124 | 12409112 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Unknown | Y | 0 | ||||||||||
| 124091124 | 12409112 | 2 | PS | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | Unknown | Y | 200889 | ||||||||||
| 124091124 | 12409112 | 3 | C | FLECAINIDE | FLECAINIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 124091124 | 12409112 | 4 | C | FLECAINIDE | FLECAINIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124091124 | 12409112 | 1 | Asthma |
| 124091124 | 12409112 | 2 | Asthma |
| 124091124 | 12409112 | 3 | Arrhythmia |
| 124091124 | 12409112 | 4 | Tachycardia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124091124 | 12409112 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124091124 | 12409112 | Activated partial thromboplastin time prolonged | |
| 124091124 | 12409112 | Arrhythmia | |
| 124091124 | 12409112 | Arrhythmia supraventricular | |
| 124091124 | 12409112 | Arteriosclerosis coronary artery | |
| 124091124 | 12409112 | Atypical pneumonia | |
| 124091124 | 12409112 | Blood cholesterol increased | |
| 124091124 | 12409112 | Blood creatine phosphokinase MB increased | |
| 124091124 | 12409112 | Blood creatine phosphokinase increased | |
| 124091124 | 12409112 | Blood creatinine increased | |
| 124091124 | 12409112 | Blood immunoglobulin E increased | |
| 124091124 | 12409112 | Blood lactate dehydrogenase increased | |
| 124091124 | 12409112 | Blood pressure increased | |
| 124091124 | 12409112 | Bronchitis | |
| 124091124 | 12409112 | C-reactive protein increased | |
| 124091124 | 12409112 | Candida infection | |
| 124091124 | 12409112 | Cardiac disorder | |
| 124091124 | 12409112 | Cardiomegaly | |
| 124091124 | 12409112 | Cardiomyopathy | |
| 124091124 | 12409112 | Chronic obstructive pulmonary disease | |
| 124091124 | 12409112 | Chronic sinusitis | |
| 124091124 | 12409112 | Dyspnoea | |
| 124091124 | 12409112 | Ejection fraction decreased | |
| 124091124 | 12409112 | Electrocardiogram ST segment depression | |
| 124091124 | 12409112 | Electrocardiogram T wave inversion | |
| 124091124 | 12409112 | Endocarditis fibroplastica | |
| 124091124 | 12409112 | Eosinophilia | |
| 124091124 | 12409112 | Eosinophilic granulomatosis with polyangiitis | |
| 124091124 | 12409112 | Erythema | |
| 124091124 | 12409112 | Extrasystoles | |
| 124091124 | 12409112 | Fatigue | |
| 124091124 | 12409112 | Granulomatosis with polyangiitis | |
| 124091124 | 12409112 | High density lipoprotein decreased | |
| 124091124 | 12409112 | Hilar lymphadenopathy | |
| 124091124 | 12409112 | Hypereosinophilic syndrome | |
| 124091124 | 12409112 | Hyperplasia | |
| 124091124 | 12409112 | Hypokinesia | |
| 124091124 | 12409112 | Low density lipoprotein increased | |
| 124091124 | 12409112 | Lymphostasis | |
| 124091124 | 12409112 | Myocarditis | |
| 124091124 | 12409112 | Palpitations | |
| 124091124 | 12409112 | Performance status decreased | |
| 124091124 | 12409112 | Pericardial effusion | |
| 124091124 | 12409112 | Pleural effusion | |
| 124091124 | 12409112 | Pulmonary function test decreased | |
| 124091124 | 12409112 | Sarcoidosis | |
| 124091124 | 12409112 | Supraventricular tachycardia | |
| 124091124 | 12409112 | Tachycardia | |
| 124091124 | 12409112 | Troponin T increased | |
| 124091124 | 12409112 | White blood cell count increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |