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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127965151 | 12796515 | 1 | I | 20160922 | 20160929 | 20160929 | PER | US-ALEXION PHARMACEUTICALS INC.-A201607225 | ALEXION | 0.00 | F | Y | 89.00000 | KG | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127965151 | 12796515 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | U | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 127965151 | 12796515 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | U | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 127965151 | 12796515 | 3 | C | HYDROCODONE | HYDROCODONE | 1 | Oral | 7.5MG/325MG (1 TAB EVERY 6HRS AS NEEDED) | 0 | TABLET | Q6H | ||||||||
| 127965151 | 12796515 | 4 | C | GRANISETRON | GRANISETRON | 1 | Oral | 1 MG, Q12H (1 TAB AS NEEDED) | 0 | 1 | MG | TABLET | Q12H | ||||||
| 127965151 | 12796515 | 5 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127965151 | 12796515 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 127965151 | 12796515 | 3 | Pain |
| 127965151 | 12796515 | 4 | Nausea |
| 127965151 | 12796515 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127965151 | 12796515 | Back pain | |
| 127965151 | 12796515 | Drug ineffective | |
| 127965151 | 12796515 | Feeling abnormal | |
| 127965151 | 12796515 | Headache | |
| 127965151 | 12796515 | Incorrect dose administered | |
| 127965151 | 12796515 | Infusion related reaction | |
| 127965151 | 12796515 | Memory impairment | |
| 127965151 | 12796515 | Menstruation irregular | |
| 127965151 | 12796515 | Musculoskeletal pain | |
| 127965151 | 12796515 | Neck pain | |
| 127965151 | 12796515 | Pain | |
| 127965151 | 12796515 | Polycystic ovaries | |
| 127965151 | 12796515 | Serum sickness | |
| 127965151 | 12796515 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 127965151 | 12796515 | 1 | 201304 | 0 |