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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123947204 | 12394720 | 4 | F | 201511 | 20160707 | 20160523 | 20160715 | EXP | PHHY2015AT147388 | NOVARTIS | 0.00 | E | F | Y | 72.00000 | KG | 20160716 | MD | AT | AT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123947204 | 12394720 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Unknown | 5 MG, QD 1-0-0 | Y | 22334 | 5 | MG | TABLET | QD | |||||
| 123947204 | 12394720 | 2 | C | EXEMESTAN | EXEMESTANE | 1 | Unknown | 25 MG, UNK | U | 0 | 25 | MG | |||||||
| 123947204 | 12394720 | 3 | C | XARELTO | RIVAROXABAN | 1 | Unknown | 15 MG, QD (1-0-1) | U | 0 | 15 | MG | FILM-COATED TABLET | QD | |||||
| 123947204 | 12394720 | 4 | C | BISOPROLOL | BISOPROLOL | 1 | Unknown | 5 MG, QD (1-0-0) | U | 0 | 5 | MG | QD | ||||||
| 123947204 | 12394720 | 5 | C | EUTHYROX | LEVOTHYROXINE SODIUM | 1 | Unknown | 75 UG, QD (1-0-0) (MONDAY, WEDNESDAY, FRIDAY) | U | 0 | 75 | UG | TABLET | QD | |||||
| 123947204 | 12394720 | 6 | C | EUTHYROX | LEVOTHYROXINE SODIUM | 1 | Unknown | 50 UG, QD (1-0-0) | U | 0 | 50 | UG | TABLET | QD | |||||
| 123947204 | 12394720 | 7 | C | GALVUS | VILDAGLIPTIN | 1 | Unknown | 50 MG, QD (0-0-1) | U | 0 | 50 | MG | QD | ||||||
| 123947204 | 12394720 | 8 | C | NOVALGIN | METAMIZOLE SODIUM | 1 | Unknown | 30 GTT, Q8H | U | 0 | 30 | GTT | Q8H | ||||||
| 123947204 | 12394720 | 9 | C | MIRTAZAPIN | MIRTAZAPINE | 1 | Unknown | 30 MG, QD (0-0-1/2) | U | 0 | |||||||||
| 123947204 | 12394720 | 10 | C | PANTOPRAZOL | PANTOPRAZOLE SODIUM | 1 | Unknown | 40 MG, QD (1-0-0) | U | 0 | 40 | MG | QD | ||||||
| 123947204 | 12394720 | 11 | C | OLEOVIT D3 | CHOLECALCIFEROL | 1 | Unknown | 30 GTT, QW | U | 0 | 30 | GTT | /wk | ||||||
| 123947204 | 12394720 | 12 | C | GLURENORM | 2 | Unknown | 1/2-0-0 | U | 0 | ||||||||||
| 123947204 | 12394720 | 13 | C | MOVICOL PLAIN | 2 | Unknown | UNK UNK, QD (1-0-0) | U | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123947204 | 12394720 | 1 | Breast cancer |
| 123947204 | 12394720 | 2 | Product used for unknown indication |
| 123947204 | 12394720 | 3 | Product used for unknown indication |
| 123947204 | 12394720 | 4 | Product used for unknown indication |
| 123947204 | 12394720 | 5 | Product used for unknown indication |
| 123947204 | 12394720 | 7 | Product used for unknown indication |
| 123947204 | 12394720 | 8 | Product used for unknown indication |
| 123947204 | 12394720 | 9 | Product used for unknown indication |
| 123947204 | 12394720 | 10 | Product used for unknown indication |
| 123947204 | 12394720 | 11 | Product used for unknown indication |
| 123947204 | 12394720 | 12 | Product used for unknown indication |
| 123947204 | 12394720 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123947204 | 12394720 | HO |
| 123947204 | 12394720 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123947204 | 12394720 | Atrial fibrillation | |
| 123947204 | 12394720 | Atrioventricular block first degree | |
| 123947204 | 12394720 | Blood alkaline phosphatase increased | |
| 123947204 | 12394720 | Blood cholesterol increased | |
| 123947204 | 12394720 | Blood creatine phosphokinase increased | |
| 123947204 | 12394720 | Blood fibrinogen increased | |
| 123947204 | 12394720 | Blood glucose increased | |
| 123947204 | 12394720 | Blood lactate dehydrogenase increased | |
| 123947204 | 12394720 | Blood triglycerides increased | |
| 123947204 | 12394720 | C-reactive protein increased | |
| 123947204 | 12394720 | Cardiomegaly | |
| 123947204 | 12394720 | Chronic kidney disease | |
| 123947204 | 12394720 | Dyspnoea | |
| 123947204 | 12394720 | Eosinophil percentage increased | |
| 123947204 | 12394720 | Gamma-glutamyltransferase increased | |
| 123947204 | 12394720 | Gastrooesophageal reflux disease | |
| 123947204 | 12394720 | Glycosylated haemoglobin increased | |
| 123947204 | 12394720 | Goitre | |
| 123947204 | 12394720 | Groin pain | |
| 123947204 | 12394720 | Haematocrit decreased | |
| 123947204 | 12394720 | Haemoglobin decreased | |
| 123947204 | 12394720 | Hallucination | |
| 123947204 | 12394720 | Headache | |
| 123947204 | 12394720 | Hypersensitivity | |
| 123947204 | 12394720 | Hyperuricaemia | |
| 123947204 | 12394720 | Lymphocyte count decreased | |
| 123947204 | 12394720 | Monocyte percentage increased | |
| 123947204 | 12394720 | Muscle tone disorder | |
| 123947204 | 12394720 | Myoclonus | |
| 123947204 | 12394720 | Nausea | |
| 123947204 | 12394720 | Neutrophil percentage increased | |
| 123947204 | 12394720 | Pain | |
| 123947204 | 12394720 | Platelet count decreased | |
| 123947204 | 12394720 | Rib fracture | |
| 123947204 | 12394720 | 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 |
|---|---|---|---|---|---|---|
| 123947204 | 12394720 | 1 | 20150626 | 20160524 | 0 | |
| 123947204 | 12394720 | 2 | 20150626 | 0 |