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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113450038 | 11345003 | 8 | F | 20150730 | 20160823 | 20150806 | 20160906 | EXP | GB-SA-2015SA113838 | AVENTIS | 77.00 | YR | E | F | Y | 0.00000 | 20160906 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113450038 | 11345003 | 1 | PS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | U | UNKNOWN | 20449 | |||||||||
| 113450038 | 11345003 | 2 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Subcutaneous | U | UNKNOWN | 0 | 300 | MG | SOLUTION FOR INJECTION | /cycle | |||||
| 113450038 | 11345003 | 3 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Subcutaneous | U | UNKNOWN | 0 | 300 | MG | SOLUTION FOR INJECTION | /cycle | |||||
| 113450038 | 11345003 | 4 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Subcutaneous | ADMINISTERED IN LOWER ABDOMEN?CYCLE 2 | U | UNKNOWN | 0 | 300 | MG | SOLUTION FOR INJECTION | /cycle | ||||
| 113450038 | 11345003 | 5 | SS | PERTUZUMAB | PERTUZUMAB | 1 | Unknown | U | UNKNOWN | 0 | 420 | MG | |||||||
| 113450038 | 11345003 | 6 | SS | PERTUZUMAB | PERTUZUMAB | 1 | Unknown | ADMINISTERED IN LOWER ABDOMEN | U | UNKNOWN | 0 | 420 | MG | ||||||
| 113450038 | 11345003 | 7 | SS | NEULASTA | PEGFILGRASTIM | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 113450038 | 11345003 | 8 | SS | NEULASTA | PEGFILGRASTIM | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 113450038 | 11345003 | 9 | C | XGEVA | DENOSUMAB | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113450038 | 11345003 | 5 | Product used for unknown indication |
| 113450038 | 11345003 | 6 | Product used for unknown indication |
| 113450038 | 11345003 | 9 | Metastases to bone |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113450038 | 11345003 | HO |
| 113450038 | 11345003 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113450038 | 11345003 | Alopecia | |
| 113450038 | 11345003 | Anxiety | |
| 113450038 | 11345003 | Arthralgia | |
| 113450038 | 11345003 | Asthenia | |
| 113450038 | 11345003 | Bone pain | |
| 113450038 | 11345003 | Breast mass | |
| 113450038 | 11345003 | Cellulitis | |
| 113450038 | 11345003 | Chest discomfort | |
| 113450038 | 11345003 | Chronic obstructive pulmonary disease | |
| 113450038 | 11345003 | Constipation | |
| 113450038 | 11345003 | Contusion | |
| 113450038 | 11345003 | Cough | |
| 113450038 | 11345003 | Decreased appetite | |
| 113450038 | 11345003 | Device dislocation | |
| 113450038 | 11345003 | Diarrhoea | |
| 113450038 | 11345003 | Dysgeusia | |
| 113450038 | 11345003 | Dyspnoea | |
| 113450038 | 11345003 | Dyspnoea exertional | |
| 113450038 | 11345003 | Fatigue | |
| 113450038 | 11345003 | Feeling abnormal | |
| 113450038 | 11345003 | Gingival pain | |
| 113450038 | 11345003 | Glossodynia | |
| 113450038 | 11345003 | Headache | |
| 113450038 | 11345003 | Hypoaesthesia | |
| 113450038 | 11345003 | Hypophagia | |
| 113450038 | 11345003 | Influenza like illness | |
| 113450038 | 11345003 | Insomnia | |
| 113450038 | 11345003 | Irritable bowel syndrome | |
| 113450038 | 11345003 | Lethargy | |
| 113450038 | 11345003 | Lower respiratory tract infection | |
| 113450038 | 11345003 | Mastectomy | |
| 113450038 | 11345003 | Micturition urgency | |
| 113450038 | 11345003 | Mouth ulceration | |
| 113450038 | 11345003 | Musculoskeletal discomfort | |
| 113450038 | 11345003 | Nausea | |
| 113450038 | 11345003 | Onychoclasis | |
| 113450038 | 11345003 | Oral candidiasis | |
| 113450038 | 11345003 | Oral pain | |
| 113450038 | 11345003 | Pain in extremity | |
| 113450038 | 11345003 | Paraesthesia | |
| 113450038 | 11345003 | Paraesthesia oral | |
| 113450038 | 11345003 | Pollakiuria | |
| 113450038 | 11345003 | Productive cough | |
| 113450038 | 11345003 | Scar | |
| 113450038 | 11345003 | Sensory disturbance | |
| 113450038 | 11345003 | Seroma | |
| 113450038 | 11345003 | Tongue coated | |
| 113450038 | 11345003 | Ulcer | |
| 113450038 | 11345003 | Urinary tract infection | |
| 113450038 | 11345003 | Vaginal prolapse | |
| 113450038 | 11345003 | Vascular fragility | |
| 113450038 | 11345003 | 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 |
|---|---|---|---|---|---|---|
| 113450038 | 11345003 | 4 | 20150729 | 20150729 | 0 | |
| 113450038 | 11345003 | 7 | 20150730 | 0 |