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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122553755 | 12255375 | 5 | F | 20160331 | 20160711 | 20160412 | 20160714 | EXP | CA-ALEXION PHARMACEUTICALS INC-A201602484 | ALEXION | 31.19 | YR | M | Y | 84.81000 | KG | 20160714 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122553755 | 12255375 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 122553755 | 12255375 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AD9022B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 122553755 | 12255375 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AD9299B04 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 122553755 | 12255375 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AE1229B05 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 122553755 | 12255375 | 5 | C | EPREX | ERYTHROPOIETIN | 1 | Subcutaneous | UNK, QW | 0 | /wk | |||||||||
| 122553755 | 12255375 | 6 | C | ADALAT | NIFEDIPINE | 1 | Oral | 20 MG, QD | 46260 | MG | 0 | 20 | MG | QD | |||||
| 122553755 | 12255375 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 122553755 | 12255375 | 8 | C | OXYCODONE | OXYCODONE | 1 | Oral | 5 MG, PRN | 0 | 5 | MG | /yr | |||||||
| 122553755 | 12255375 | 9 | C | MAGNESIUM | MAGNESIUM | 1 | Oral | 6 TABLETS , QD | 0 | TABLET | QD | ||||||||
| 122553755 | 12255375 | 10 | C | APO-PEN-VK | 2 | Oral | 300 MG, TID | 0 | 300 | MG | TID | ||||||||
| 122553755 | 12255375 | 11 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | Oral | 500 MG, PRN | 0 | 500 | MG | /yr | |||||||
| 122553755 | 12255375 | 12 | C | PANTOLOC /01263204/ | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG, BID | 0 | 40 | MG | BID | |||||||
| 122553755 | 12255375 | 13 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | 1 MG 2 CO, BID | 0 | BID | |||||||||
| 122553755 | 12255375 | 14 | C | ADVIL | IBUPROFEN | 1 | Oral | UNK, PRN | 0 | /yr | |||||||||
| 122553755 | 12255375 | 15 | C | MORPHINE | MORPHINE | 1 | Subcutaneous | UNK, PRN | 0 | /yr | |||||||||
| 122553755 | 12255375 | 16 | C | APO-CIPROFLOX | CIPROFLOXACIN | 1 | Oral | 500 MG, BID X 14 DAYS | 0 | 500 | MG | BID | |||||||
| 122553755 | 12255375 | 17 | C | CIPRO XL | CIPROFLOXACINCIPROFLOXACIN HYDROCHLORIDE | 1 | Oral | 1000 MG, QD | 0 | 1000 | MG | QD | |||||||
| 122553755 | 12255375 | 18 | C | TAMSULOSIN SANDOZ | TAMSULOSIN | 1 | Oral | 0.4 MG, QD (FOR ONE MONTH) | 0 | .4 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122553755 | 12255375 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 122553755 | 12255375 | 5 | Product used for unknown indication |
| 122553755 | 12255375 | 6 | Hypertension |
| 122553755 | 12255375 | 7 | Supplementation therapy |
| 122553755 | 12255375 | 8 | Pain |
| 122553755 | 12255375 | 9 | Supplementation therapy |
| 122553755 | 12255375 | 10 | Infection prophylaxis |
| 122553755 | 12255375 | 11 | Pain |
| 122553755 | 12255375 | 12 | Prophylaxis |
| 122553755 | 12255375 | 13 | Aplastic anaemia |
| 122553755 | 12255375 | 14 | Nasopharyngitis |
| 122553755 | 12255375 | 15 | Pain |
| 122553755 | 12255375 | 16 | Product used for unknown indication |
| 122553755 | 12255375 | 17 | Bacterial infection |
| 122553755 | 12255375 | 18 | Prostatomegaly |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122553755 | 12255375 | HO |
| 122553755 | 12255375 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122553755 | 12255375 | Arthralgia | |
| 122553755 | 12255375 | Back pain | |
| 122553755 | 12255375 | Chromaturia | |
| 122553755 | 12255375 | Feeling of body temperature change | |
| 122553755 | 12255375 | Haemoglobin decreased | |
| 122553755 | 12255375 | Headache | |
| 122553755 | 12255375 | Hypotension | |
| 122553755 | 12255375 | Nephrolithiasis | |
| 122553755 | 12255375 | Pain in extremity | |
| 122553755 | 12255375 | 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 |
|---|---|---|---|---|---|---|
| 122553755 | 12255375 | 1 | 20110818 | 20110908 | 0 | |
| 122553755 | 12255375 | 2 | 20110915 | 0 | ||
| 122553755 | 12255375 | 3 | 20110915 | 0 | ||
| 122553755 | 12255375 | 4 | 20110915 | 0 | ||
| 122553755 | 12255375 | 5 | 20091201 | 0 | ||
| 122553755 | 12255375 | 6 | 20091201 | 20160401 | 0 | |
| 122553755 | 12255375 | 7 | 20091201 | 0 | ||
| 122553755 | 12255375 | 8 | 201006 | 0 | ||
| 122553755 | 12255375 | 9 | 201206 | 0 | ||
| 122553755 | 12255375 | 10 | 20110815 | 0 | ||
| 122553755 | 12255375 | 13 | 20120228 | 0 | ||
| 122553755 | 12255375 | 14 | 20150517 | 0 | ||
| 122553755 | 12255375 | 15 | 20160331 | 0 | ||
| 122553755 | 12255375 | 16 | 20160403 | 0 | ||
| 122553755 | 12255375 | 17 | 20160509 | 0 | ||
| 122553755 | 12255375 | 18 | 20160509 | 0 |