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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124090526 | 12409052 | 6 | F | 201603 | 20160823 | 20160526 | 20160826 | EXP | PHHY2016BR045443 | NOVARTIS | 60.01 | YR | F | Y | 72.00000 | KG | 20160826 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124090526 | 12409052 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 1 DF OF 10 MG, QD | SA822/SA835 | 22334 | 1 | DF | TABLET | QD | |||||
| 124090526 | 12409052 | 2 | C | CALCIUM | CALCIUM | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124090526 | 12409052 | 1 | Breast cancer metastatic |
| 124090526 | 12409052 | 2 | Bone disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124090526 | 12409052 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124090526 | 12409052 | Abdominal discomfort | |
| 124090526 | 12409052 | Abdominal pain | |
| 124090526 | 12409052 | Anger | |
| 124090526 | 12409052 | Aptyalism | |
| 124090526 | 12409052 | Arthralgia | |
| 124090526 | 12409052 | Arthropathy | |
| 124090526 | 12409052 | Asthenia | |
| 124090526 | 12409052 | Back pain | |
| 124090526 | 12409052 | Blood calcium decreased | |
| 124090526 | 12409052 | Blood urine present | |
| 124090526 | 12409052 | Confusional state | |
| 124090526 | 12409052 | Contusion | |
| 124090526 | 12409052 | Cough | |
| 124090526 | 12409052 | Decreased appetite | |
| 124090526 | 12409052 | Dry mouth | |
| 124090526 | 12409052 | Dysuria | |
| 124090526 | 12409052 | Fluid intake reduced | |
| 124090526 | 12409052 | Micturition frequency decreased | |
| 124090526 | 12409052 | Mouth injury | |
| 124090526 | 12409052 | Musculoskeletal stiffness | |
| 124090526 | 12409052 | Nausea | |
| 124090526 | 12409052 | Oral disorder | |
| 124090526 | 12409052 | Pain | |
| 124090526 | 12409052 | Pruritus generalised | |
| 124090526 | 12409052 | Skin lesion | |
| 124090526 | 12409052 | Sleep disorder due to general medical condition, insomnia type | |
| 124090526 | 12409052 | Spinal osteoarthritis | |
| 124090526 | 12409052 | Spinal pain | |
| 124090526 | 12409052 | Stomatitis | |
| 124090526 | 12409052 | Urinary tract infection | |
| 124090526 | 12409052 | Urinary tract pain |
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 |
|---|---|---|---|---|---|---|
| 124090526 | 12409052 | 1 | 20160314 | 0 | ||
| 124090526 | 12409052 | 2 | 2013 | 0 |