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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126469131 | 12646913 | 1 | I | 20141130 | 20160808 | 20160812 | 20160812 | EXP | GB-MHRA-ADR 23590518 | GB-ACCORD-043202 | ACCORD | 46.00 | YR | A | F | Y | 58.50000 | KG | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126469131 | 12646913 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | CYCLES 1-4, 500 MG/M2 | 40743 | 850 | MG | ||||||||
| 126469131 | 12646913 | 2 | SS | EPIRUBICIN | EPIRUBICIN | 1 | Intravenous (not otherwise specified) | 100 MG/M2 | Y | 2147483647 | 170 | MG | |||||||
| 126469131 | 12646913 | 3 | SS | CYCLOPHOSPHAMIDE/CYCLOPHOSPHAMIDE MONOHYDRATE | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 600 MG/M2 | Y | 0 | 1020 | MG | Q3W | ||||||
| 126469131 | 12646913 | 4 | SS | DOMPERIDONE/DOMPERIDONE MALEATE | DOMPERIDONEDOMPERIDONE MALEATE | 1 | Oral | 0 | 10 | MG | |||||||||
| 126469131 | 12646913 | 5 | C | CODEINE | CODEINE | 1 | Oral | 0 | 30 | MG | |||||||||
| 126469131 | 12646913 | 6 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 8 | MG | |||||||||
| 126469131 | 12646913 | 7 | C | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG/M**2 | Q3W | ||||||||
| 126469131 | 12646913 | 8 | C | GRANULOCYTE COLONY STIMULATING | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Subcutaneous | 0 | 300 | UG | |||||||||
| 126469131 | 12646913 | 9 | C | IBUPROFEN. | IBUPROFEN | 1 | Oral | 0 | 200 | MG | |||||||||
| 126469131 | 12646913 | 10 | C | LOPERAMIDE | LOPERAMIDE | 1 | Oral | 0 | 2 | MG | |||||||||
| 126469131 | 12646913 | 11 | C | ONDANSETRON/ONDANSETRON HYDROCHLORIDE | 2 | Oral | 0 | 8 | MG | ||||||||||
| 126469131 | 12646913 | 12 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 1 | G | |||||||||
| 126469131 | 12646913 | 13 | C | PERTUZUMAB | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | DAY 1 OF CYCLE 1 ONLY. | 0 | 840 | MG | ||||||||
| 126469131 | 12646913 | 14 | C | POTASSIUM BICARBONATE. | POTASSIUM BICARBONATE | 1 | Oral | 0 | |||||||||||
| 126469131 | 12646913 | 15 | C | TRASTUZUMAB | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | DAY 1 OF CYCLE 1 | 0 | 8 | MG/KG | ||||||||
| 126469131 | 12646913 | 16 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126469131 | 12646913 | 1 | HER-2 positive breast cancer |
| 126469131 | 12646913 | 2 | HER-2 positive breast cancer |
| 126469131 | 12646913 | 3 | HER-2 positive breast cancer |
| 126469131 | 12646913 | 4 | Product used for unknown indication |
| 126469131 | 12646913 | 5 | Headache |
| 126469131 | 12646913 | 7 | HER-2 positive breast cancer |
| 126469131 | 12646913 | 12 | Headache |
| 126469131 | 12646913 | 13 | HER-2 positive breast cancer |
| 126469131 | 12646913 | 14 | Blood potassium decreased |
| 126469131 | 12646913 | 15 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126469131 | 12646913 | LT |
| 126469131 | 12646913 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126469131 | 12646913 | Alopecia | |
| 126469131 | 12646913 | Anaemia | |
| 126469131 | 12646913 | Back pain | |
| 126469131 | 12646913 | Bone pain | |
| 126469131 | 12646913 | Constipation | |
| 126469131 | 12646913 | Diarrhoea | |
| 126469131 | 12646913 | Dysgeusia | |
| 126469131 | 12646913 | Headache | |
| 126469131 | 12646913 | Hypotension | |
| 126469131 | 12646913 | Mouth ulceration | |
| 126469131 | 12646913 | Nausea | |
| 126469131 | 12646913 | Neutropenic sepsis | |
| 126469131 | 12646913 | Oropharyngeal pain | |
| 126469131 | 12646913 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 126469131 | 12646913 | 1 | 20141029 | 0 | ||
| 126469131 | 12646913 | 2 | 20141029 | 0 | ||
| 126469131 | 12646913 | 3 | 20141029 | 0 | ||
| 126469131 | 12646913 | 4 | 20141030 | 20150405 | 0 | |
| 126469131 | 12646913 | 5 | 20141125 | 20150603 | 0 | |
| 126469131 | 12646913 | 6 | 20141029 | 20141231 | 0 | |
| 126469131 | 12646913 | 8 | 20141105 | 20150413 | 0 | |
| 126469131 | 12646913 | 9 | 20141110 | 20160119 | 0 | |
| 126469131 | 12646913 | 10 | 20141223 | 0 | ||
| 126469131 | 12646913 | 11 | 20141019 | 20141231 | 0 | |
| 126469131 | 12646913 | 12 | 20141105 | 20141124 | 0 | |
| 126469131 | 12646913 | 13 | 20150129 | 0 | ||
| 126469131 | 12646913 | 14 | 20141223 | 20141226 | 0 | |
| 126469131 | 12646913 | 15 | 20150129 | 0 |