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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1006717415 | 10067174 | 15 | F | 2014 | 20150319 | 20140409 | 20150331 | EXP | US-ALEXION PHARMACEUTICALS INC.-A201401166 | ALEXION | 0.00 | Y | 0.00000 | 20150331 | N | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1006717415 | 10067174 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | INTRAVENOUS | 900 MG, 4 DAYS | D | T2-AB5118D,T2-AB5117C | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
| 1006717415 | 10067174 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | INTRAVENOUS | 1200 MG, Q2W | D | T2-AB5118D,T2-AB5117C | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 1006717415 | 10067174 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | ORAL | 10 MG, BID | D | 0 | 10 | MG | BID | ||||||
| 1006717415 | 10067174 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | UNKNOWN | 60 MG, UNK | D | 0 | 60 | MG | |||||||
| 1006717415 | 10067174 | 5 | C | INSULIN | INSULIN NOS | 1 | UNKNOWN | UNK | D | 0 | |||||||||
| 1006717415 | 10067174 | 6 | C | ASA | ASPIRIN | 1 | UNKNOWN | D | 0 | ||||||||||
| 1006717415 | 10067174 | 7 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | UNKNOWN | UNK | D | 0 | |||||||||
| 1006717415 | 10067174 | 8 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNKNOWN | UNK | D | 0 | |||||||||
| 1006717415 | 10067174 | 9 | C | METOPROLOL | METOPROLOL | 1 | UNKNOWN | UNK | D | 0 | |||||||||
| 1006717415 | 10067174 | 10 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | ORAL | UNK | D | 0 | |||||||||
| 1006717415 | 10067174 | 11 | C | CALCIUM ACETATE. | CALCIUM ACETATE | 1 | UNKNOWN | UNK | D | 0 | |||||||||
| 1006717415 | 10067174 | 12 | C | EPOETIN | ERYTHROPOIETIN | 1 | UNKNOWN | UNK | D | 0 | |||||||||
| 1006717415 | 10067174 | 13 | C | ZEMPLAR | PARICALCITOL | 1 | UNKNOWN | UNK | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1006717415 | 10067174 | 1 | Haemolytic uraemic syndrome |
| 1006717415 | 10067174 | 3 | Steroid therapy |
| 1006717415 | 10067174 | 4 | Clostridium difficile infection |
| 1006717415 | 10067174 | 5 | Diabetes mellitus |
| 1006717415 | 10067174 | 6 | Product used for unknown indication |
| 1006717415 | 10067174 | 7 | Product used for unknown indication |
| 1006717415 | 10067174 | 8 | Product used for unknown indication |
| 1006717415 | 10067174 | 9 | Product used for unknown indication |
| 1006717415 | 10067174 | 10 | Prophylaxis |
| 1006717415 | 10067174 | 11 | Product used for unknown indication |
| 1006717415 | 10067174 | 12 | Product used for unknown indication |
| 1006717415 | 10067174 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1006717415 | 10067174 | OT |
| 1006717415 | 10067174 | HO |
| 1006717415 | 10067174 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1006717415 | 10067174 | Abasia | |
| 1006717415 | 10067174 | Abdominal distension | |
| 1006717415 | 10067174 | Asthenia | |
| 1006717415 | 10067174 | Bacteraemia | |
| 1006717415 | 10067174 | Bacterial infection | |
| 1006717415 | 10067174 | Blood creatinine increased | |
| 1006717415 | 10067174 | Blood glucose abnormal | |
| 1006717415 | 10067174 | Blood lactate dehydrogenase decreased | |
| 1006717415 | 10067174 | Brain natriuretic peptide increased | |
| 1006717415 | 10067174 | Chest pain | |
| 1006717415 | 10067174 | Clostridium difficile infection | |
| 1006717415 | 10067174 | Death | |
| 1006717415 | 10067174 | Depression | |
| 1006717415 | 10067174 | Dyspnoea | |
| 1006717415 | 10067174 | Fistula | |
| 1006717415 | 10067174 | Fungal infection | |
| 1006717415 | 10067174 | Gait disturbance | |
| 1006717415 | 10067174 | Gastrointestinal haemorrhage | |
| 1006717415 | 10067174 | Haematocrit abnormal | |
| 1006717415 | 10067174 | Haematocrit decreased | |
| 1006717415 | 10067174 | Haemoglobin abnormal | |
| 1006717415 | 10067174 | Haemoglobin decreased | |
| 1006717415 | 10067174 | Haemorrhage | |
| 1006717415 | 10067174 | Headache | |
| 1006717415 | 10067174 | Herpes zoster | |
| 1006717415 | 10067174 | Hypertension | |
| 1006717415 | 10067174 | Infection | |
| 1006717415 | 10067174 | Nausea | |
| 1006717415 | 10067174 | Neuralgia | |
| 1006717415 | 10067174 | Oedema peripheral | |
| 1006717415 | 10067174 | Pain in extremity | |
| 1006717415 | 10067174 | Panic attack | |
| 1006717415 | 10067174 | Peripheral swelling | |
| 1006717415 | 10067174 | Platelet count decreased | |
| 1006717415 | 10067174 | Pneumonia | |
| 1006717415 | 10067174 | Pneumonitis | |
| 1006717415 | 10067174 | Poor venous access | |
| 1006717415 | 10067174 | Pulmonary haemorrhage | |
| 1006717415 | 10067174 | Rash | |
| 1006717415 | 10067174 | Rectal haemorrhage | |
| 1006717415 | 10067174 | Retinopathy | |
| 1006717415 | 10067174 | Seizure | |
| 1006717415 | 10067174 | Sepsis | |
| 1006717415 | 10067174 | Swelling | |
| 1006717415 | 10067174 | Thrombotic microangiopathy | |
| 1006717415 | 10067174 | Troponin increased | |
| 1006717415 | 10067174 | Vision blurred | |
| 1006717415 | 10067174 | 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 |
|---|---|---|---|---|---|---|
| 1006717415 | 10067174 | 1 | 20140323 | 0 | ||
| 1006717415 | 10067174 | 2 | 20140323 | 0 | ||
| 1006717415 | 10067174 | 3 | 20140301 | 0 | ||
| 1006717415 | 10067174 | 5 | 20140416 | 0 | ||
| 1006717415 | 10067174 | 8 | 201406 | 0 | ||
| 1006717415 | 10067174 | 10 | 201406 | 0 |