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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1117970317 | 11179703 | 17 | F | 20050512 | 20160914 | 20150611 | 20160921 | EXP | GB-ALXN-A201502162AA | ALEXION | 41.46 | YR | M | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1117970317 | 11179703 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 1117970317 | 11179703 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0002902 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 1117970317 | 11179703 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0003003 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 1117970317 | 11179703 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0003003 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 1117970317 | 11179703 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0003202 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 1117970317 | 11179703 | 6 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0003704 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 1117970317 | 11179703 | 7 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0003801 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1117970317 | 11179703 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1117970317 | 11179703 | DS |
| 1117970317 | 11179703 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1117970317 | 11179703 | Abdominal discomfort | |
| 1117970317 | 11179703 | Abdominal distension | |
| 1117970317 | 11179703 | Abdominal pain upper | |
| 1117970317 | 11179703 | Alopecia | |
| 1117970317 | 11179703 | Arthralgia | |
| 1117970317 | 11179703 | Back pain | |
| 1117970317 | 11179703 | Bone pain | |
| 1117970317 | 11179703 | Chest discomfort | |
| 1117970317 | 11179703 | Chromaturia | |
| 1117970317 | 11179703 | Constipation | |
| 1117970317 | 11179703 | Deafness | |
| 1117970317 | 11179703 | Diarrhoea | |
| 1117970317 | 11179703 | Dysphagia | |
| 1117970317 | 11179703 | Dyspnoea | |
| 1117970317 | 11179703 | Dyspnoea exertional | |
| 1117970317 | 11179703 | Ear congestion | |
| 1117970317 | 11179703 | Fatigue | |
| 1117970317 | 11179703 | Gastrointestinal disorder | |
| 1117970317 | 11179703 | Groin pain | |
| 1117970317 | 11179703 | Haemolysis | |
| 1117970317 | 11179703 | Incorrect dose administered | |
| 1117970317 | 11179703 | Influenza like illness | |
| 1117970317 | 11179703 | Insomnia | |
| 1117970317 | 11179703 | Jaundice | |
| 1117970317 | 11179703 | Lacrimation increased | |
| 1117970317 | 11179703 | Malaise | |
| 1117970317 | 11179703 | Musculoskeletal stiffness | |
| 1117970317 | 11179703 | Nasopharyngitis | |
| 1117970317 | 11179703 | Neck pain | |
| 1117970317 | 11179703 | Ocular hyperaemia | |
| 1117970317 | 11179703 | Pain | |
| 1117970317 | 11179703 | Pain in extremity | |
| 1117970317 | 11179703 | Paraesthesia | |
| 1117970317 | 11179703 | Pollakiuria | |
| 1117970317 | 11179703 | Sinus congestion | |
| 1117970317 | 11179703 | Sleep disorder | |
| 1117970317 | 11179703 | Swelling | |
| 1117970317 | 11179703 | Tinnitus | |
| 1117970317 | 11179703 | Vitamin D decreased |
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 |
|---|---|---|---|---|---|---|
| 1117970317 | 11179703 | 1 | 20050512 | 20071122 | 0 | |
| 1117970317 | 11179703 | 2 | 20071122 | 0 | ||
| 1117970317 | 11179703 | 5 | 20050512 | 0 | ||
| 1117970317 | 11179703 | 6 | 20050512 | 0 | ||
| 1117970317 | 11179703 | 7 | 20050512 | 0 |