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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123400732 | 12340073 | 2 | F | 20160609 | 20160628 | 20160506 | 20160705 | EXP | PHEH2016US011285 | NOVARTIS | 75.98 | YR | F | Y | 177.00000 | KG | 20160705 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123400732 | 12340073 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | 22334 | 5 | MG | TABLET | QD | ||||||
| 123400732 | 12340073 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | 22334 | 10 | MG | TABLET | QD | ||||||
| 123400732 | 12340073 | 3 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | Unknown | U | 0 | ||||||||||
| 123400732 | 12340073 | 4 | C | CALCIUM | CALCIUM | 1 | Unknown | U | 0 | ||||||||||
| 123400732 | 12340073 | 5 | C | EXEMESTANE. | EXEMESTANE | 1 | Unknown | U | 0 | ||||||||||
| 123400732 | 12340073 | 6 | C | GLUCOSAMIN CHONDROITIN /01430901/ | 2 | Unknown | U | 0 | |||||||||||
| 123400732 | 12340073 | 7 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | Unknown | U | 0 | ||||||||||
| 123400732 | 12340073 | 8 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 123400732 | 12340073 | 9 | C | SOMATULIN | LANREOTIDE ACETATE | 1 | Unknown | U | 0 | ||||||||||
| 123400732 | 12340073 | 10 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | U | 0 | ||||||||||
| 123400732 | 12340073 | 11 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | U | 0 | ||||||||||
| 123400732 | 12340073 | 12 | C | COUMADIN | WARFARIN SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 123400732 | 12340073 | 13 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123400732 | 12340073 | 1 | Breast cancer |
| 123400732 | 12340073 | 3 | Product used for unknown indication |
| 123400732 | 12340073 | 4 | Product used for unknown indication |
| 123400732 | 12340073 | 5 | Product used for unknown indication |
| 123400732 | 12340073 | 6 | Product used for unknown indication |
| 123400732 | 12340073 | 7 | Product used for unknown indication |
| 123400732 | 12340073 | 8 | Product used for unknown indication |
| 123400732 | 12340073 | 9 | Product used for unknown indication |
| 123400732 | 12340073 | 10 | Product used for unknown indication |
| 123400732 | 12340073 | 11 | Product used for unknown indication |
| 123400732 | 12340073 | 12 | International normalised ratio increased |
| 123400732 | 12340073 | 13 | Coagulopathy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123400732 | 12340073 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123400732 | 12340073 | Back pain | |
| 123400732 | 12340073 | Coagulopathy | |
| 123400732 | 12340073 | Full blood count decreased | |
| 123400732 | 12340073 | Gastrointestinal haemorrhage | |
| 123400732 | 12340073 | International normalised ratio increased | |
| 123400732 | 12340073 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 123400732 | 12340073 | 1 | 20160407 | 0 | ||
| 123400732 | 12340073 | 2 | 201605 | 0 |