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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125608568 | 12560856 | 8 | F | 201606 | 20160802 | 20160715 | 20160816 | EXP | GB-WATSON-2016-15439 | ACTAVIS | 69.00 | YR | F | Y | 0.00000 | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125608568 | 12560856 | 1 | SS | Dexamethasone (Unknown) | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 8 MG, DAILY | UNCONFIRMED | 0 | 8 | MG | UNK | QD | |||||
| 125608568 | 12560856 | 2 | PS | Epirubicin (Unknown) | EPIRUBICIN | 1 | Intravenous (not otherwise specified) | 126 MG, CYCLICAL, | UNCONFIRMED | 65445 | 126 | MG | UNK | ||||||
| 125608568 | 12560856 | 3 | SS | Ondansetron (Unknown) | ONDANSETRON | 1 | Intravenous (not otherwise specified) | 8 MG, UNK | UNCONFIRMED | 0 | 8 | MG | UNK | ||||||
| 125608568 | 12560856 | 4 | SS | Metoclopramide (Unknown) | METOCLOPRAMIDE | 1 | Unknown | UNK, DAILY, REDUCED DOSE | UNCONFIRMED | 0 | UNK | QD | |||||||
| 125608568 | 12560856 | 5 | SS | EMEND | APREPITANT | 1 | Oral | 125 MG, DAILY | 0 | 125 | MG | QD | |||||||
| 125608568 | 12560856 | 6 | SS | NEULASTA | PEGFILGRASTIM | 1 | Subcutaneous | 6 MG, CYCLICAL, CYCLE 1/6, BY A PAXMAN SCALP COOLER | 0 | 6 | MG | ||||||||
| 125608568 | 12560856 | 7 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 0.9 MG, CYCLICAL | 0 | .9 | MG | ||||||||
| 125608568 | 12560856 | 8 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | UNK UNK, CYCLICAL | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125608568 | 12560856 | 1 | Product used for unknown indication |
| 125608568 | 12560856 | 2 | Breast cancer |
| 125608568 | 12560856 | 3 | Product used for unknown indication |
| 125608568 | 12560856 | 4 | Product used for unknown indication |
| 125608568 | 12560856 | 5 | Product used for unknown indication |
| 125608568 | 12560856 | 6 | Breast cancer |
| 125608568 | 12560856 | 7 | Product used for unknown indication |
| 125608568 | 12560856 | 8 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125608568 | 12560856 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125608568 | 12560856 | Alopecia | |
| 125608568 | 12560856 | Body temperature abnormal | |
| 125608568 | 12560856 | Condition aggravated | |
| 125608568 | 12560856 | Cough | |
| 125608568 | 12560856 | Diarrhoea | |
| 125608568 | 12560856 | Dyspnoea | |
| 125608568 | 12560856 | Ear pain | |
| 125608568 | 12560856 | Eating disorder | |
| 125608568 | 12560856 | Fatigue | |
| 125608568 | 12560856 | Feeling abnormal | |
| 125608568 | 12560856 | Glossodynia | |
| 125608568 | 12560856 | Headache | |
| 125608568 | 12560856 | Hypophagia | |
| 125608568 | 12560856 | Intercepted drug administration error | |
| 125608568 | 12560856 | Lethargy | |
| 125608568 | 12560856 | Lower respiratory tract infection | |
| 125608568 | 12560856 | Malaise | |
| 125608568 | 12560856 | Nausea | |
| 125608568 | 12560856 | Odynophagia | |
| 125608568 | 12560856 | Oral pain | |
| 125608568 | 12560856 | Oropharyngeal pain | |
| 125608568 | 12560856 | Pharyngeal erythema | |
| 125608568 | 12560856 | Productive cough | |
| 125608568 | 12560856 | Sputum discoloured | |
| 125608568 | 12560856 | 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 |
|---|---|---|---|---|---|---|
| 125608568 | 12560856 | 2 | 20160608 | 0 | ||
| 125608568 | 12560856 | 7 | 20160608 | 0 | ||
| 125608568 | 12560856 | 8 | 20160608 | 0 |