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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112021517 | 11202151 | 7 | F | 201411 | 20160901 | 20150619 | 20160902 | EXP | PHHY2015AT036859 | NOVARTIS | 59.00 | YR | F | Y | 80.00000 | KG | 20160902 | MD | AT | AT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112021517 | 11202151 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Unknown | 5 MG, UNK | 22334 | 5 | MG | TABLET | |||||||
| 112021517 | 11202151 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Unknown | 5 MG, UNK | 22334 | 5 | MG | TABLET | |||||||
| 112021517 | 11202151 | 3 | C | XGEVA | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | 0 | 120 | MG | ||||||||
| 112021517 | 11202151 | 4 | C | ABRAXANE | PACLITAXEL | 1 | Unknown | 1 DF, WEEDLY, CYCLE I | 0 | 1 | DF | ||||||||
| 112021517 | 11202151 | 5 | C | PANTOLOC | PANTOPRAZOLE SODIUM | 1 | Unknown | 40 MG, 1-0-0 | 0 | 40 | MG | ||||||||
| 112021517 | 11202151 | 6 | C | FORTECORTIN | DEXAMETHASONE | 1 | Unknown | 4 MG, 1-0-1 DAY BEFORE THERAPY, DAY OF CHEMOTHERAPY, DAY AFTER THERAPY | 0 | 4 | MG | ||||||||
| 112021517 | 11202151 | 7 | C | GRANISETRON | GRANISETRON | 1 | Unknown | 2 MG, 1-0-0- FOR 3-5 DAYS AFTER CHEMOTHERAPY | 0 | 2 | MG | ||||||||
| 112021517 | 11202151 | 8 | C | LAEVOLAC | LACTULOSE | 1 | Unknown | 1-2 MEASURING CUPS | 0 | ||||||||||
| 112021517 | 11202151 | 9 | C | CALCIUM GLYCEROPHOSPHATECELLULOSEPOLYETHYLENE GLYCOLSACCHARIN SODIUMSODIUM HYDROXIDESODIUM LAURYL SULFATESODIUM MAGNESIUM SILICATESODIUM MONOFLUOROPHOSPHATESORBITOLWATER | CALCIUM GLYCEROPHOSPHATEPOLYETHYLENE GLYCOLSPOWDERED CELLULOSESACCHARIN SODIUM DIHYDRATESODIUM HYDROXIDESODIUM LAURYL SULFATESODIUM MAGNESIUM SILICATESODIUM MONOFLUOROPHOSPHATESORBITOLWATER | 1 | Unknown | 1-2 BAGS | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112021517 | 11202151 | 1 | Breast cancer |
| 112021517 | 11202151 | 3 | Product used for unknown indication |
| 112021517 | 11202151 | 4 | Product used for unknown indication |
| 112021517 | 11202151 | 5 | Product used for unknown indication |
| 112021517 | 11202151 | 6 | Product used for unknown indication |
| 112021517 | 11202151 | 7 | Product used for unknown indication |
| 112021517 | 11202151 | 8 | Constipation |
| 112021517 | 11202151 | 9 | Constipation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112021517 | 11202151 | OT |
| 112021517 | 11202151 | HO |
| 112021517 | 11202151 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112021517 | 11202151 | Alopecia | |
| 112021517 | 11202151 | Angular cheilitis | |
| 112021517 | 11202151 | Asthma | |
| 112021517 | 11202151 | Blood chloride increased | |
| 112021517 | 11202151 | Bone pain | |
| 112021517 | 11202151 | Breast cancer | |
| 112021517 | 11202151 | C-reactive protein increased | |
| 112021517 | 11202151 | Conjunctival haemorrhage | |
| 112021517 | 11202151 | Contusion | |
| 112021517 | 11202151 | Discomfort | |
| 112021517 | 11202151 | Dysgeusia | |
| 112021517 | 11202151 | Dyspnoea exertional | |
| 112021517 | 11202151 | Epistaxis | |
| 112021517 | 11202151 | Eye haemorrhage | |
| 112021517 | 11202151 | Fatigue | |
| 112021517 | 11202151 | General physical health deterioration | |
| 112021517 | 11202151 | Haematoma | |
| 112021517 | 11202151 | Haemoglobin decreased | |
| 112021517 | 11202151 | Hepatic encephalopathy | |
| 112021517 | 11202151 | Hypotension | |
| 112021517 | 11202151 | Insomnia | |
| 112021517 | 11202151 | Metastases to bone | |
| 112021517 | 11202151 | Metastases to central nervous system | |
| 112021517 | 11202151 | Metastases to liver | |
| 112021517 | 11202151 | Metastases to lymph nodes | |
| 112021517 | 11202151 | Metastasis | |
| 112021517 | 11202151 | Mite allergy | |
| 112021517 | 11202151 | Mucosal dryness | |
| 112021517 | 11202151 | Nasal congestion | |
| 112021517 | 11202151 | Oedema peripheral | |
| 112021517 | 11202151 | Pain | |
| 112021517 | 11202151 | Pancytopenia | |
| 112021517 | 11202151 | Platelet count decreased | |
| 112021517 | 11202151 | Pyrexia | |
| 112021517 | 11202151 | Seasonal allergy | |
| 112021517 | 11202151 | Skin abrasion | |
| 112021517 | 11202151 | Stomatitis | |
| 112021517 | 11202151 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 112021517 | 11202151 | 1 | 20141113 | 20150428 | 0 | |
| 112021517 | 11202151 | 2 | 20150508 | 20150608 | 0 | |
| 112021517 | 11202151 | 3 | 20150619 | 0 | ||
| 112021517 | 11202151 | 4 | 20150616 | 0 |