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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116189842 | 11618984 | 2 | F | 20121025 | 20160823 | 20151012 | 20160911 | EXP | PHHY2013JP040397 | NOVARTIS | 76.27 | YR | M | Y | 56.00000 | KG | 20160911 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116189842 | 11618984 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | 1000 | MG | Y | 22334 | 10 | MG | TABLET | QD | |||
| 116189842 | 11618984 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | 1000 | MG | Y | 22334 | 5 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116189842 | 11618984 | 1 | Pancreatic neuroendocrine tumour |
| 116189842 | 11618984 | 2 | Neuroendocrine tumour |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116189842 | 11618984 | OT |
| 116189842 | 11618984 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116189842 | 11618984 | Anaemia | |
| 116189842 | 11618984 | Atrial fibrillation | |
| 116189842 | 11618984 | Blood albumin decreased | |
| 116189842 | 11618984 | Cardiac failure | |
| 116189842 | 11618984 | Cough | |
| 116189842 | 11618984 | Decreased appetite | |
| 116189842 | 11618984 | Dyspnoea | |
| 116189842 | 11618984 | Hypoproteinaemia | |
| 116189842 | 11618984 | Jaundice | |
| 116189842 | 11618984 | Malignant neoplasm progression | |
| 116189842 | 11618984 | Mitral valve incompetence | |
| 116189842 | 11618984 | Oedema peripheral | |
| 116189842 | 11618984 | Pleural effusion | |
| 116189842 | 11618984 | Pneumonia bacterial | |
| 116189842 | 11618984 | Pulmonary hypertension | |
| 116189842 | 11618984 | Pyrexia | |
| 116189842 | 11618984 | Stomatitis | |
| 116189842 | 11618984 | Tricuspid valve incompetence | |
| 116189842 | 11618984 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 116189842 | 11618984 | 1 | 20121004 | 20130111 | 0 | |
| 116189842 | 11618984 | 2 | 20130321 | 20130513 | 0 |