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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122169906 | 12216990 | 6 | F | 201603 | 20160706 | 20160329 | 20160712 | EXP | PHEH2016US007452 | NOVARTIS | 82.07 | YR | F | Y | 65.86000 | KG | 20160712 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122169906 | 12216990 | 1 | PS | FEMARA | LETROZOLE | 1 | Unknown | U | 20726 | ||||||||||
| 122169906 | 12216990 | 2 | SS | FEMARA | LETROZOLE | 1 | U | 20726 | |||||||||||
| 122169906 | 12216990 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | Y | 0 | 10 | MG | QD | ||||||
| 122169906 | 12216990 | 4 | SS | AFINITOR | EVEROLIMUS | 1 | Y | 0 | |||||||||||
| 122169906 | 12216990 | 5 | SS | PALBOCICLIB | PALBOCICLIB | 1 | Unknown | 75 MG, 21 DAYS ON 7 DAYS OFF | U | 0 | 75 | MG | |||||||
| 122169906 | 12216990 | 6 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | UNK | U | 0 | |||||||||
| 122169906 | 12216990 | 7 | C | MOTRIN | IBUPROFEN | 1 | Unknown | UNK | U | 0 | |||||||||
| 122169906 | 12216990 | 8 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 122169906 | 12216990 | 9 | C | TAXOTERE | DOCETAXEL | 1 | Unknown | 75 MG/M2, TIW | Y | 0 | 75 | MG/M**2 | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122169906 | 12216990 | 1 | Breast cancer female |
| 122169906 | 12216990 | 2 | Invasive ductal breast carcinoma |
| 122169906 | 12216990 | 3 | Breast cancer female |
| 122169906 | 12216990 | 4 | Invasive ductal breast carcinoma |
| 122169906 | 12216990 | 5 | Product used for unknown indication |
| 122169906 | 12216990 | 6 | Product used for unknown indication |
| 122169906 | 12216990 | 7 | Product used for unknown indication |
| 122169906 | 12216990 | 8 | Product used for unknown indication |
| 122169906 | 12216990 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122169906 | 12216990 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122169906 | 12216990 | Anaemia | |
| 122169906 | 12216990 | Anxiety | |
| 122169906 | 12216990 | Asthenia | |
| 122169906 | 12216990 | Blood pressure increased | |
| 122169906 | 12216990 | Body temperature decreased | |
| 122169906 | 12216990 | Breast cancer metastatic | |
| 122169906 | 12216990 | Breast swelling | |
| 122169906 | 12216990 | Confusional state | |
| 122169906 | 12216990 | Decreased appetite | |
| 122169906 | 12216990 | Diarrhoea | |
| 122169906 | 12216990 | Dry mouth | |
| 122169906 | 12216990 | Duodenal ulcer | |
| 122169906 | 12216990 | Erythema | |
| 122169906 | 12216990 | Faeces discoloured | |
| 122169906 | 12216990 | Fatigue | |
| 122169906 | 12216990 | Feeling abnormal | |
| 122169906 | 12216990 | Gastrointestinal haemorrhage | |
| 122169906 | 12216990 | Hypermetabolism | |
| 122169906 | 12216990 | Inflammatory carcinoma of the breast | |
| 122169906 | 12216990 | Lymphoedema | |
| 122169906 | 12216990 | Malignant neoplasm progression | |
| 122169906 | 12216990 | Neutropenia | |
| 122169906 | 12216990 | Oedema | |
| 122169906 | 12216990 | Oedema peripheral | |
| 122169906 | 12216990 | Oesophageal candidiasis | |
| 122169906 | 12216990 | Pain | |
| 122169906 | 12216990 | Pain in extremity | |
| 122169906 | 12216990 | Peripheral swelling | |
| 122169906 | 12216990 | Skin discolouration | |
| 122169906 | 12216990 | Tumour pain | |
| 122169906 | 12216990 | Upper gastrointestinal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 122169906 | 12216990 | 1 | 20150801 | 0 | ||
| 122169906 | 12216990 | 3 | 20160316 | 20160420 | 0 | |
| 122169906 | 12216990 | 5 | 20150915 | 0 | ||
| 122169906 | 12216990 | 9 | 20160504 | 20160526 | 0 |