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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119495748 | 11949574 | 8 | F | 20140616 | 20160928 | 20160125 | 20160930 | EXP | PHHY2016DE008834 | NOVARTIS | 0.00 | E | F | Y | 73.00000 | KG | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119495748 | 11949574 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | D | 22334 | 10 | MG | TABLET | QD | |||||
| 119495748 | 11949574 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | D | 22334 | 10 | MG | TABLET | QD | |||||
| 119495748 | 11949574 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 05 MG, QD | D | 22334 | 5 | MG | TABLET | QD | |||||
| 119495748 | 11949574 | 4 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 05 MG, QD | D | 22334 | 5 | MG | TABLET | QD | |||||
| 119495748 | 11949574 | 5 | SS | CAELYX | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 65 MG, QD | D | 0 | 65 | MG | QD | ||||||
| 119495748 | 11949574 | 6 | C | EXEMESTANE. | EXEMESTANE | 1 | Oral | 25 MG, QD | D | 0 | 25 | MG | QD | ||||||
| 119495748 | 11949574 | 7 | C | METOBETA | 2 | Oral | 100 MG, QD | D | 0 | 100 | MG | QD | |||||||
| 119495748 | 11949574 | 8 | C | RAMIPRIL. | RAMIPRIL | 1 | Oral | 5 MG, QD | D | 0 | 5 | MG | QD | ||||||
| 119495748 | 11949574 | 9 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | Unknown | UNK UNK, QD | D | 0 | QD | ||||||||
| 119495748 | 11949574 | 10 | C | PANTOZOL | PANTOPRAZOLE SODIUM | 1 | Unknown | 40 MG, QD | D | 0 | 40 | MG | QD | ||||||
| 119495748 | 11949574 | 11 | C | FOLICOMBIN | 2 | Unknown | UNK UNK, QD | D | 0 | QD | |||||||||
| 119495748 | 11949574 | 12 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | UNK UNK, QD (ACCORDING TO BLOOD SUGAR) | D | 0 | QD | ||||||||
| 119495748 | 11949574 | 13 | C | DUROGESIC | FENTANYL | 1 | Oral | 100 UG, UNK (EVERY 3 DAYS) | D | 0 | 100 | UG | |||||||
| 119495748 | 11949574 | 14 | C | XGEVA | DENOSUMAB | 1 | Unknown | 120 MG, QMO | D | 0 | 120 | MG | /month |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119495748 | 11949574 | 1 | Breast cancer metastatic |
| 119495748 | 11949574 | 5 | Product used for unknown indication |
| 119495748 | 11949574 | 6 | Breast cancer metastatic |
| 119495748 | 11949574 | 7 | Hypertension |
| 119495748 | 11949574 | 8 | Hypertension |
| 119495748 | 11949574 | 9 | Product used for unknown indication |
| 119495748 | 11949574 | 10 | Product used for unknown indication |
| 119495748 | 11949574 | 11 | Product used for unknown indication |
| 119495748 | 11949574 | 12 | Diabetes mellitus |
| 119495748 | 11949574 | 13 | Product used for unknown indication |
| 119495748 | 11949574 | 14 | Metastases to bone |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119495748 | 11949574 | OT |
| 119495748 | 11949574 | LT |
| 119495748 | 11949574 | HO |
| 119495748 | 11949574 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119495748 | 11949574 | Aortic arteriosclerosis | |
| 119495748 | 11949574 | Aortic calcification | |
| 119495748 | 11949574 | Aortic dilatation | |
| 119495748 | 11949574 | Aortic valve disease | |
| 119495748 | 11949574 | Aortic valve incompetence | |
| 119495748 | 11949574 | Aortic valve stenosis | |
| 119495748 | 11949574 | Atrial fibrillation | |
| 119495748 | 11949574 | Atrial flutter | |
| 119495748 | 11949574 | Biliary dilatation | |
| 119495748 | 11949574 | Bladder mass | |
| 119495748 | 11949574 | C-reactive protein increased | |
| 119495748 | 11949574 | Cardiac failure | |
| 119495748 | 11949574 | Cardiac murmur | |
| 119495748 | 11949574 | Carotid arteriosclerosis | |
| 119495748 | 11949574 | Degenerative mitral valve disease | |
| 119495748 | 11949574 | Dyspnoea exertional | |
| 119495748 | 11949574 | Faecaloma | |
| 119495748 | 11949574 | Fatigue | |
| 119495748 | 11949574 | Gamma-glutamyltransferase increased | |
| 119495748 | 11949574 | General physical health deterioration | |
| 119495748 | 11949574 | Haemoglobin decreased | |
| 119495748 | 11949574 | Hepatomegaly | |
| 119495748 | 11949574 | Klebsiella test positive | |
| 119495748 | 11949574 | Left atrial enlargement | |
| 119495748 | 11949574 | Left ventricular dysfunction | |
| 119495748 | 11949574 | Left ventricular hypertrophy | |
| 119495748 | 11949574 | Malignant neoplasm progression | |
| 119495748 | 11949574 | Mitral valve calcification | |
| 119495748 | 11949574 | Mitral valve incompetence | |
| 119495748 | 11949574 | Nausea | |
| 119495748 | 11949574 | Nephrocalcinosis | |
| 119495748 | 11949574 | Oedema peripheral | |
| 119495748 | 11949574 | Palpitations | |
| 119495748 | 11949574 | Pancreatic atrophy | |
| 119495748 | 11949574 | Pancreatic steatosis | |
| 119495748 | 11949574 | Pleural effusion | |
| 119495748 | 11949574 | Pulmonary congestion | |
| 119495748 | 11949574 | Toxicity to various agents | |
| 119495748 | 11949574 | Weight 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 |
|---|---|---|---|---|---|---|
| 119495748 | 11949574 | 1 | 20130903 | 20130912 | 0 | |
| 119495748 | 11949574 | 2 | 20130919 | 20130920 | 0 | |
| 119495748 | 11949574 | 3 | 20131002 | 20131223 | 0 | |
| 119495748 | 11949574 | 4 | 20140107 | 20140730 | 0 | |
| 119495748 | 11949574 | 5 | 20151022 | 20151022 | 0 | |
| 119495748 | 11949574 | 6 | 20130903 | 20140730 | 0 | |
| 119495748 | 11949574 | 7 | 201307 | 0 | ||
| 119495748 | 11949574 | 8 | 201307 | 0 | ||
| 119495748 | 11949574 | 9 | 201307 | 0 | ||
| 119495748 | 11949574 | 10 | 201307 | 0 | ||
| 119495748 | 11949574 | 11 | 201307 | 0 | ||
| 119495748 | 11949574 | 12 | 201307 | 0 | ||
| 119495748 | 11949574 | 13 | 201307 | 0 | ||
| 119495748 | 11949574 | 14 | 20130903 | 20131104 | 0 |