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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1131595018 | 11315950 | 18 | F | 20150730 | 20160823 | 20150728 | 20160901 | EXP | GB-ROCHE-1607682 | ROCHE | 77.00 | YR | F | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1131595018 | 11315950 | 1 | PS | HERCEPTIN | TRASTUZUMAB | 1 | Subcutaneous | CYCLE 8, CYCLE 10 | U | 103792 | 300 | MG | SOLUTION FOR INJECTION | ||||||
| 1131595018 | 11315950 | 2 | SS | Pertuzumab | PERTUZUMAB | 1 | Unknown | CYCLE 8, CYCLE 10 | U | 125409 | 420 | MG | |||||||
| 1131595018 | 11315950 | 3 | SS | NEULASTA | PEGFILGRASTIM | 1 | Unknown | U | 0 | ||||||||||
| 1131595018 | 11315950 | 4 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 103792 | 300 | MG | SOLUTION FOR INFUSION | ||||||||
| 1131595018 | 11315950 | 5 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | U | 0 | ||||||||||
| 1131595018 | 11315950 | 6 | C | XGEVA | DENOSUMAB | 1 | 0 | ||||||||||||
| 1131595018 | 11315950 | 7 | C | XGEVA | DENOSUMAB | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1131595018 | 11315950 | 1 | Product used for unknown indication |
| 1131595018 | 11315950 | 2 | Product used for unknown indication |
| 1131595018 | 11315950 | 3 | Product used for unknown indication |
| 1131595018 | 11315950 | 4 | Product used for unknown indication |
| 1131595018 | 11315950 | 5 | Product used for unknown indication |
| 1131595018 | 11315950 | 6 | Breast cancer |
| 1131595018 | 11315950 | 7 | Metastases to bone |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1131595018 | 11315950 | HO |
| 1131595018 | 11315950 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1131595018 | 11315950 | Alopecia | |
| 1131595018 | 11315950 | Anxiety | |
| 1131595018 | 11315950 | Arthralgia | |
| 1131595018 | 11315950 | Asthenia | |
| 1131595018 | 11315950 | Bone pain | |
| 1131595018 | 11315950 | Breast mass | |
| 1131595018 | 11315950 | Cellulitis | |
| 1131595018 | 11315950 | Chest discomfort | |
| 1131595018 | 11315950 | Chronic obstructive pulmonary disease | |
| 1131595018 | 11315950 | Constipation | |
| 1131595018 | 11315950 | Contusion | |
| 1131595018 | 11315950 | Cough | |
| 1131595018 | 11315950 | Decreased appetite | |
| 1131595018 | 11315950 | Device dislocation | |
| 1131595018 | 11315950 | Diarrhoea | |
| 1131595018 | 11315950 | Dysgeusia | |
| 1131595018 | 11315950 | Dyspnoea | |
| 1131595018 | 11315950 | Dyspnoea exertional | |
| 1131595018 | 11315950 | Fatigue | |
| 1131595018 | 11315950 | Feeling abnormal | |
| 1131595018 | 11315950 | Gingival pain | |
| 1131595018 | 11315950 | Glossodynia | |
| 1131595018 | 11315950 | Headache | |
| 1131595018 | 11315950 | Hypoaesthesia | |
| 1131595018 | 11315950 | Hypophagia | |
| 1131595018 | 11315950 | Influenza like illness | |
| 1131595018 | 11315950 | Insomnia | |
| 1131595018 | 11315950 | Irritable bowel syndrome | |
| 1131595018 | 11315950 | Lethargy | |
| 1131595018 | 11315950 | Lower respiratory tract infection | |
| 1131595018 | 11315950 | Micturition urgency | |
| 1131595018 | 11315950 | Mouth ulceration | |
| 1131595018 | 11315950 | Musculoskeletal discomfort | |
| 1131595018 | 11315950 | Nausea | |
| 1131595018 | 11315950 | Onychoclasis | |
| 1131595018 | 11315950 | Oral candidiasis | |
| 1131595018 | 11315950 | Oral pain | |
| 1131595018 | 11315950 | Pain in extremity | |
| 1131595018 | 11315950 | Paraesthesia | |
| 1131595018 | 11315950 | Paraesthesia oral | |
| 1131595018 | 11315950 | Pollakiuria | |
| 1131595018 | 11315950 | Productive cough | |
| 1131595018 | 11315950 | Scar | |
| 1131595018 | 11315950 | Sensory disturbance | |
| 1131595018 | 11315950 | Seroma | |
| 1131595018 | 11315950 | Tongue coated | |
| 1131595018 | 11315950 | Ulcer | |
| 1131595018 | 11315950 | Urinary tract infection | |
| 1131595018 | 11315950 | Vaginal prolapse | |
| 1131595018 | 11315950 | Vascular fragility | |
| 1131595018 | 11315950 | Vein disorder |
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 |
|---|---|---|---|---|---|---|
| 1131595018 | 11315950 | 3 | 20150730 | 0 |