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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 980542515 | 9805425 | 15 | F | 20131204 | 20160909 | 20140109 | 20160919 | EXP | US-ALEXION PHARMACEUTICALS INC.-A201400001 | ALEXION | 49.61 | YR | M | Y | 0.00000 | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 980542515 | 9805425 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | Y | T2-AB5118D | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 980542515 | 9805425 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | Y | T3-AB4066D | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 980542515 | 9805425 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | Y | T2-AC1963B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 980542515 | 9805425 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG,Q2W | Y | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 980542515 | 9805425 | 5 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 980542515 | 9805425 | 6 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 5 MG, UNK | 0 | 5 | MG | ||||||||
| 980542515 | 9805425 | 7 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 980542515 | 9805425 | 8 | C | CLARITIN | LORATADINE | 1 | Unknown | UNK | 0 | ||||||||||
| 980542515 | 9805425 | 9 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 980542515 | 9805425 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 980542515 | 9805425 | 5 | Pain in extremity |
| 980542515 | 9805425 | 6 | Hypertension |
| 980542515 | 9805425 | 7 | Product used for unknown indication |
| 980542515 | 9805425 | 8 | Product used for unknown indication |
| 980542515 | 9805425 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 980542515 | 9805425 | HO |
| 980542515 | 9805425 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 980542515 | 9805425 | Blood lactate dehydrogenase increased | |
| 980542515 | 9805425 | Blood potassium abnormal | |
| 980542515 | 9805425 | Deep vein thrombosis | |
| 980542515 | 9805425 | Dyspnoea | |
| 980542515 | 9805425 | Fatigue | |
| 980542515 | 9805425 | Gastrointestinal anastomotic leak | |
| 980542515 | 9805425 | Gastrointestinal perforation | |
| 980542515 | 9805425 | Haemoglobin decreased | |
| 980542515 | 9805425 | Haemolysis | |
| 980542515 | 9805425 | Headache | |
| 980542515 | 9805425 | Incorrect dose administered | |
| 980542515 | 9805425 | Lethargy | |
| 980542515 | 9805425 | Myalgia | |
| 980542515 | 9805425 | Nausea | |
| 980542515 | 9805425 | Pain | |
| 980542515 | 9805425 | Pain in extremity | |
| 980542515 | 9805425 | Peripheral swelling | |
| 980542515 | 9805425 | Post procedural haemorrhage | |
| 980542515 | 9805425 | Pyrexia | |
| 980542515 | 9805425 | Surgery | |
| 980542515 | 9805425 | Thrombosis | |
| 980542515 | 9805425 | Ulcer haemorrhage | |
| 980542515 | 9805425 | Vomiting | |
| 980542515 | 9805425 | Weight 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 |
|---|---|---|---|---|---|---|
| 980542515 | 9805425 | 1 | 20131204 | 0 | ||
| 980542515 | 9805425 | 2 | 20131204 | 0 | ||
| 980542515 | 9805425 | 3 | 20131204 | 0 | ||
| 980542515 | 9805425 | 4 | 20160902 | 0 | ||
| 980542515 | 9805425 | 6 | 20131201 | 0 | ||
| 980542515 | 9805425 | 7 | 19990909 | 0 | ||
| 980542515 | 9805425 | 8 | 19990909 | 0 |