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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125630903 | 12563090 | 3 | F | 201606 | 20160802 | 20160715 | 20160811 | EXP | GB-MYLANLABS-2016M1028354 | MYLAN | 0.00 | Y | 0.00000 | 20160811 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125630903 | 12563090 | 1 | PS | EPIRUBICIN | EPIRUBICIN | 1 | Intravenous (not otherwise specified) | 126 MG, CYCLE,CYCLE 1/6, BY A PAXMAN SCALP COOLER | U | 91599 | 126 | MG | |||||||
| 125630903 | 12563090 | 2 | SS | EPIRUBICIN | EPIRUBICIN | 1 | UNK | U | 91599 | ||||||||||
| 125630903 | 12563090 | 3 | SS | ONDANSETRON | ONDANSETRON | 1 | Intravenous (not otherwise specified) | 8 MG, UNK | U | 0 | 8 | MG | INJECTION | ||||||
| 125630903 | 12563090 | 4 | SS | EMEND | APREPITANT | 1 | Oral | 125 MG, CYCLE | U | 0 | 125 | MG | |||||||
| 125630903 | 12563090 | 5 | SS | EMEND | APREPITANT | 1 | 1 DF, CYCLE | U | 0 | 1 | DF | ||||||||
| 125630903 | 12563090 | 6 | SS | NEULASTA | PEGFILGRASTIM | 1 | Subcutaneous | 6 MG, CYCLE 1/6 | U | 0 | 6 | MG | QD | ||||||
| 125630903 | 12563090 | 7 | SS | NEULASTA | PEGFILGRASTIM | 1 | UNK | U | 0 | ||||||||||
| 125630903 | 12563090 | 8 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 0.9 MG, QD (0.9 MG, CYCLE 1/6) | U | 0 | .9 | MG | QD | ||||||
| 125630903 | 12563090 | 9 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 8 MG, QD | U | 0 | 8 | MG | QD | ||||||
| 125630903 | 12563090 | 10 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | CYCLE 1/6, BY A PAXMAN SCALP COOLER, REDUCED DOSE | U | 0 | |||||||||
| 125630903 | 12563090 | 11 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | UNK | U | 0 | ||||||||||
| 125630903 | 12563090 | 12 | SS | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Unknown | 1 DF, CYCLE | U | 0 | 1 | DF |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125630903 | 12563090 | 1 | Breast cancer |
| 125630903 | 12563090 | 2 | Product used for unknown indication |
| 125630903 | 12563090 | 3 | Product used for unknown indication |
| 125630903 | 12563090 | 4 | Product used for unknown indication |
| 125630903 | 12563090 | 6 | Breast cancer |
| 125630903 | 12563090 | 7 | Product used for unknown indication |
| 125630903 | 12563090 | 8 | Product used for unknown indication |
| 125630903 | 12563090 | 9 | Product used for unknown indication |
| 125630903 | 12563090 | 10 | Breast cancer |
| 125630903 | 12563090 | 11 | Product used for unknown indication |
| 125630903 | 12563090 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125630903 | 12563090 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125630903 | 12563090 | Alopecia | |
| 125630903 | 12563090 | Body temperature abnormal | |
| 125630903 | 12563090 | Condition aggravated | |
| 125630903 | 12563090 | Cough | |
| 125630903 | 12563090 | Diarrhoea | |
| 125630903 | 12563090 | Dyspnoea | |
| 125630903 | 12563090 | Ear pain | |
| 125630903 | 12563090 | Eating disorder | |
| 125630903 | 12563090 | Fatigue | |
| 125630903 | 12563090 | Feeling abnormal | |
| 125630903 | 12563090 | Glossodynia | |
| 125630903 | 12563090 | Headache | |
| 125630903 | 12563090 | Hypophagia | |
| 125630903 | 12563090 | Intercepted drug administration error | |
| 125630903 | 12563090 | Lethargy | |
| 125630903 | 12563090 | Lower respiratory tract infection | |
| 125630903 | 12563090 | Malaise | |
| 125630903 | 12563090 | Nausea | |
| 125630903 | 12563090 | Odynophagia | |
| 125630903 | 12563090 | Oral pain | |
| 125630903 | 12563090 | Oropharyngeal pain | |
| 125630903 | 12563090 | Pharyngeal erythema | |
| 125630903 | 12563090 | Productive cough | |
| 125630903 | 12563090 | Sputum discoloured | |
| 125630903 | 12563090 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125630903 | 12563090 | 1 | 20160608 | 0 | ||
| 125630903 | 12563090 | 6 | 20160608 | 0 | ||
| 125630903 | 12563090 | 8 | 20160608 | 0 | ||
| 125630903 | 12563090 | 10 | 20160608 | 0 |