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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122678249 | 12267824 | 9 | F | 20160327 | 20160824 | 20160414 | 20160901 | EXP | PHEH2016US008848 | SANDOZ | 65.60 | YR | F | Y | 99.77000 | KG | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122678249 | 12267824 | 1 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | 0 | 10 | MG | TABLET | QD | ||||||
| 122678249 | 12267824 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | 0 | 5 | MG | TABLET | QD | ||||||
| 122678249 | 12267824 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG, QD | 0 | 7.5 | MG | TABLET | QD | ||||||
| 122678249 | 12267824 | 4 | PS | ANASTROZOLE. | ANASTROZOLE | 1 | Unknown | 1 MG, QD | U | 79007 | 1 | MG | QD | ||||||
| 122678249 | 12267824 | 5 | C | AROMASIN | EXEMESTANE | 1 | Oral | 25 MG, QD | 0 | 25 | MG | TABLET | QD | ||||||
| 122678249 | 12267824 | 6 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | Unknown | 180 MG, PRN | U | 0 | 180 | MG | TABLET | ||||||
| 122678249 | 12267824 | 7 | C | BIOTIN | BIOTIN | 1 | Unknown | 7500 UG, QD | U | 0 | 7500 | UG | TABLET | QD | |||||
| 122678249 | 12267824 | 8 | C | BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHENBUTALBITAL | 1 | Unknown | UNK, PRN | U | 0 | TABLET | ||||||||
| 122678249 | 12267824 | 9 | C | CALTRATE | CALCIUM CARBONATE | 1 | Unknown | UNK, QD (600-400MG) | U | 0 | TABLET | QD | |||||||
| 122678249 | 12267824 | 10 | C | CLOTRIMAZOLE. | CLOTRIMAZOLE | 1 | Unknown | UNK | U | 0 | CREAM | ||||||||
| 122678249 | 12267824 | 11 | C | COREG | CARVEDILOL | 1 | Unknown | 12.5 MG, QD | U | 0 | 12.5 | MG | TABLET | QD | |||||
| 122678249 | 12267824 | 12 | C | ENALAPRIL MALEATE. | ENALAPRIL MALEATE | 1 | Unknown | 10 MG, QD | U | 0 | 10 | MG | TABLET | QD | |||||
| 122678249 | 12267824 | 13 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | UNK | U | 0 | TABLET | ||||||||
| 122678249 | 12267824 | 14 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Unknown | 40 MG, QD | U | 0 | 40 | MG | TABLET | QD | |||||
| 122678249 | 12267824 | 15 | C | NEURONTIN | GABAPENTIN | 1 | Unknown | 100 MG, UNK | U | 0 | 100 | MG | CAPSULE | ||||||
| 122678249 | 12267824 | 16 | C | NITROGLYCERIN. | NITROGLYCERIN | 1 | Unknown | .4 MG, PRN | U | 0 | .4 | MG | SPRAY | ||||||
| 122678249 | 12267824 | 17 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Unknown | 50 MG, QD | U | 0 | 50 | MG | TABLET | QD | |||||
| 122678249 | 12267824 | 18 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | 160-4.5UG/ACT AERO | U | 0 | 160 | UG | |||||||
| 122678249 | 12267824 | 19 | C | TIZANIDINE HCL | TIZANIDINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | CAPSULE | ||||||||
| 122678249 | 12267824 | 20 | C | TRAMADOL AND ACETAMINOPHEN | ACETAMINOPHENTRAMADOL HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | TABLET | ||||||||
| 122678249 | 12267824 | 21 | C | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | 1 | Unknown | UNK UG, UNK | U | 0 | |||||||||
| 122678249 | 12267824 | 22 | C | XOPENEX HFA | LEVALBUTEROL TARTRATE | 1 | Unknown | 45 UG/ ACT AERO | U | 0 | 45 | UG | |||||||
| 122678249 | 12267824 | 23 | C | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 150 MG, BID | U | 0 | 150 | MG | CAPSULE | BID | |||||
| 122678249 | 12267824 | 24 | C | NAPROXEN. | NAPROXEN | 1 | Unknown | 375 MG, Q12H | U | 0 | 375 | MG | Q12H | ||||||
| 122678249 | 12267824 | 25 | C | LINUM USITATISSIMUM SEED OIL | 2 | Unknown | UNK | U | 0 | ||||||||||
| 122678249 | 12267824 | 26 | C | NAPROSYN | NAPROXEN | 1 | Oral | 375 MG, BID,PRN | U | 0 | 375 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122678249 | 12267824 | 1 | Breast cancer female |
| 122678249 | 12267824 | 4 | Breast cancer |
| 122678249 | 12267824 | 5 | Breast cancer |
| 122678249 | 12267824 | 6 | Product used for unknown indication |
| 122678249 | 12267824 | 7 | Product used for unknown indication |
| 122678249 | 12267824 | 8 | Product used for unknown indication |
| 122678249 | 12267824 | 9 | Product used for unknown indication |
| 122678249 | 12267824 | 10 | Product used for unknown indication |
| 122678249 | 12267824 | 11 | Product used for unknown indication |
| 122678249 | 12267824 | 12 | Product used for unknown indication |
| 122678249 | 12267824 | 13 | Product used for unknown indication |
| 122678249 | 12267824 | 14 | Product used for unknown indication |
| 122678249 | 12267824 | 15 | Product used for unknown indication |
| 122678249 | 12267824 | 16 | Product used for unknown indication |
| 122678249 | 12267824 | 17 | Product used for unknown indication |
| 122678249 | 12267824 | 18 | Product used for unknown indication |
| 122678249 | 12267824 | 19 | Product used for unknown indication |
| 122678249 | 12267824 | 20 | Product used for unknown indication |
| 122678249 | 12267824 | 21 | Product used for unknown indication |
| 122678249 | 12267824 | 22 | Product used for unknown indication |
| 122678249 | 12267824 | 23 | Product used for unknown indication |
| 122678249 | 12267824 | 24 | Product used for unknown indication |
| 122678249 | 12267824 | 25 | Product used for unknown indication |
| 122678249 | 12267824 | 26 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122678249 | 12267824 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122678249 | 12267824 | Allergic oedema | |
| 122678249 | 12267824 | Anal incontinence | |
| 122678249 | 12267824 | Arthralgia | |
| 122678249 | 12267824 | Asthenia | |
| 122678249 | 12267824 | Cardiac failure | |
| 122678249 | 12267824 | Contusion | |
| 122678249 | 12267824 | Decreased appetite | |
| 122678249 | 12267824 | Depression | |
| 122678249 | 12267824 | Diarrhoea | |
| 122678249 | 12267824 | Dyspnoea | |
| 122678249 | 12267824 | Ecchymosis | |
| 122678249 | 12267824 | Epistaxis | |
| 122678249 | 12267824 | Fatigue | |
| 122678249 | 12267824 | Fungal infection | |
| 122678249 | 12267824 | Gait disturbance | |
| 122678249 | 12267824 | Goitre | |
| 122678249 | 12267824 | Haematoma | |
| 122678249 | 12267824 | Headache | |
| 122678249 | 12267824 | Hepatic steatosis | |
| 122678249 | 12267824 | Lymphocyte count decreased | |
| 122678249 | 12267824 | Malaise | |
| 122678249 | 12267824 | Mediastinal mass | |
| 122678249 | 12267824 | Metabolic disorder | |
| 122678249 | 12267824 | Metastases to lung | |
| 122678249 | 12267824 | Nausea | |
| 122678249 | 12267824 | Neutrophil count decreased | |
| 122678249 | 12267824 | Oedema peripheral | |
| 122678249 | 12267824 | Peripheral swelling | |
| 122678249 | 12267824 | Platelet count decreased | |
| 122678249 | 12267824 | Rash | |
| 122678249 | 12267824 | Type I hypersensitivity | |
| 122678249 | 12267824 | Urticaria | |
| 122678249 | 12267824 | Vomiting | |
| 122678249 | 12267824 | Weight decreased | |
| 122678249 | 12267824 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 122678249 | 12267824 | 1 | 20160317 | 20160413 | 0 | |
| 122678249 | 12267824 | 5 | 20151218 | 0 |