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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118935647 | 11893564 | 7 | F | 201512 | 20160829 | 20160106 | 20160906 | EXP | PHJP2016JP000489 | NOVARTIS | 71.75 | YR | F | Y | 0.00000 | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118935647 | 11893564 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | 160 | MG | Y | 22334 | 5 | MG | TABLET | QD | |||
| 118935647 | 11893564 | 2 | C | AROMASIN | EXEMESTANE | 1 | Oral | 25 MG, QD | Y | 0 | 25 | MG | TABLET | QD | |||||
| 118935647 | 11893564 | 3 | C | TRINOSIN | ADENOSINE TRIPHOSPHATE DISODIUM | 1 | Oral | 1 G, TID | 573 | G | Y | 0 | 1 | G | GRANULE | TID | |||
| 118935647 | 11893564 | 4 | C | METHYCOBAL | METHYLCOBALAMIN | 1 | Oral | 500 MG, TID | U | 0 | 500 | MG | TABLET | TID | |||||
| 118935647 | 11893564 | 5 | C | LIMAPROST ALFADEX | LIMAPROST | 1 | Oral | 10 UG, TID | U | 0 | 10 | UG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118935647 | 11893564 | 1 | Breast cancer recurrent |
| 118935647 | 11893564 | 2 | Breast cancer |
| 118935647 | 11893564 | 3 | Dizziness |
| 118935647 | 11893564 | 4 | Dizziness |
| 118935647 | 11893564 | 5 | Dizziness |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118935647 | 11893564 | OT |
| 118935647 | 11893564 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118935647 | 11893564 | Acidosis | |
| 118935647 | 11893564 | Anaemia | |
| 118935647 | 11893564 | Azotaemia | |
| 118935647 | 11893564 | Cough | |
| 118935647 | 11893564 | Decreased appetite | |
| 118935647 | 11893564 | Faeces discoloured | |
| 118935647 | 11893564 | Gastrointestinal haemorrhage | |
| 118935647 | 11893564 | Interstitial lung disease | |
| 118935647 | 11893564 | Malaise | |
| 118935647 | 11893564 | Oedema peripheral | |
| 118935647 | 11893564 | Platelet count decreased | |
| 118935647 | 11893564 | Pyrexia | |
| 118935647 | 11893564 | Renal disorder | |
| 118935647 | 11893564 | Renal failure | |
| 118935647 | 11893564 | Respiratory failure | |
| 118935647 | 11893564 | Stomatitis | |
| 118935647 | 11893564 | Stress cardiomyopathy |
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 |
|---|---|---|---|---|---|---|
| 118935647 | 11893564 | 1 | 20151204 | 20160104 | 0 | |
| 118935647 | 11893564 | 2 | 20160104 | 0 | ||
| 118935647 | 11893564 | 3 | 20150627 | 20160103 | 0 | |
| 118935647 | 11893564 | 4 | 20150627 | 0 | ||
| 118935647 | 11893564 | 5 | 20150627 | 0 |