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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111811449 | 11181144 | 9 | F | 20150521 | 20160623 | 20150611 | 20160707 | EXP | JP-ALEXION-A201502014 | ALEXION | 38.47 | YR | F | Y | 73.00000 | KG | 20160707 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111811449 | 11181144 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | AC6839D01 | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 111811449 | 11181144 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AC6939D01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 111811449 | 11181144 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AC6841D01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 111811449 | 11181144 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AD6547B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 111811449 | 11181144 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AE3116D01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 111811449 | 11181144 | 6 | SS | SOLIRIS | ECULIZUMAB | 1 | UNK | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||||
| 111811449 | 11181144 | 7 | C | BENET | RISEDRONATE SODIUM | 1 | Oral | 17.5 MG, QW | 52 | MG | Y | 0 | 17.5 | MG | /wk | ||||
| 111811449 | 11181144 | 8 | C | BENET | RISEDRONATE SODIUM | 1 | Oral | 17.5 MG, QW | 52 | MG | Y | 0 | 17.5 | MG | /wk | ||||
| 111811449 | 11181144 | 9 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 30 MG, DAILY | 0 | 30 | MG | ||||||||
| 111811449 | 11181144 | 10 | C | LASIX | FUROSEMIDE | 1 | Unknown | 60 MG, DAILY | 0 | 60 | MG | ||||||||
| 111811449 | 11181144 | 11 | C | LASIX | FUROSEMIDE | 1 | Oral | 20 MG, DAILY | 0 | 20 | MG | ||||||||
| 111811449 | 11181144 | 12 | C | LASIX | FUROSEMIDE | 1 | Oral | 40 MG, DAILY | 0 | 40 | MG | ||||||||
| 111811449 | 11181144 | 13 | C | GLUCONSAN K | 2 | Oral | 2.5 MEQ, QD | 0 | 2.5 | MEQ | QD | ||||||||
| 111811449 | 11181144 | 14 | C | AKINETON | BIPERIDEN HYDROCHLORIDE | 1 | Oral | 3 MG, QD | 0 | 3 | MG | QD | |||||||
| 111811449 | 11181144 | 15 | C | DAIKENCHUTO | HERBALS | 1 | Oral | 7.5 G, QD | 0 | 7.5 | G | QD | |||||||
| 111811449 | 11181144 | 16 | C | BENZALIN /00036201/ | NITRAZEPAM | 1 | Oral | 0.2 G, QD | 0 | .2 | G | QD | |||||||
| 111811449 | 11181144 | 17 | C | BENZALIN /00036201/ | NITRAZEPAM | 1 | Oral | 10 MG, DAILY | 0 | 10 | MG | ||||||||
| 111811449 | 11181144 | 18 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 15 MG, QD | 0 | 15 | MG | QD | |||||||
| 111811449 | 11181144 | 19 | C | RISPERDAL | RISPERIDONE | 1 | Oral | 1 MG, QD | 0 | 1 | MG | QD | |||||||
| 111811449 | 11181144 | 20 | C | RIVOTRIL | CLONAZEPAM | 1 | Oral | 1 MG, QD | 0 | 1 | MG | QD | |||||||
| 111811449 | 11181144 | 21 | C | HIRUDOID /00723701/ | PENTOSAN POLYSULFATE SODIUM | 1 | Unknown | 25 G, QD | 0 | 25 | G | QD | |||||||
| 111811449 | 11181144 | 22 | C | SOLDEM 3A | CARBOHYDRATESPOTASSIUM CHLORIDESODIUM CHLORIDESODIUM LACTATE | 1 | Intravenous (not otherwise specified) | 500 ML, QD | 3500 | ML | 0 | 500 | ML | QD | |||||
| 111811449 | 11181144 | 23 | C | HEPARIN | HEPARIN SODIUM | 1 | Intravenous (not otherwise specified) | 12 ML, QD | 0 | 12 | ML | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111811449 | 11181144 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 111811449 | 11181144 | 7 | Osteoporosis |
| 111811449 | 11181144 | 9 | Product used for unknown indication |
| 111811449 | 11181144 | 10 | Product used for unknown indication |
| 111811449 | 11181144 | 13 | Product used for unknown indication |
| 111811449 | 11181144 | 14 | Product used for unknown indication |
| 111811449 | 11181144 | 15 | Product used for unknown indication |
| 111811449 | 11181144 | 16 | Product used for unknown indication |
| 111811449 | 11181144 | 18 | Product used for unknown indication |
| 111811449 | 11181144 | 19 | Product used for unknown indication |
| 111811449 | 11181144 | 20 | Product used for unknown indication |
| 111811449 | 11181144 | 21 | Product used for unknown indication |
| 111811449 | 11181144 | 22 | Product used for unknown indication |
| 111811449 | 11181144 | 23 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111811449 | 11181144 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111811449 | 11181144 | Abdominal pain | |
| 111811449 | 11181144 | Complement factor abnormal | |
| 111811449 | 11181144 | Drug ineffective | |
| 111811449 | 11181144 | Extravascular haemolysis | |
| 111811449 | 11181144 | Haemorrhage subcutaneous | |
| 111811449 | 11181144 | Iron overload | |
| 111811449 | 11181144 | Klebsiella infection | |
| 111811449 | 11181144 | Oedema | |
| 111811449 | 11181144 | Otitis media acute | |
| 111811449 | 11181144 | Viral infection |
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 |
|---|---|---|---|---|---|---|
| 111811449 | 11181144 | 1 | 20150422 | 20150514 | 0 | |
| 111811449 | 11181144 | 2 | 20150521 | 0 | ||
| 111811449 | 11181144 | 7 | 20090730 | 20150108 | 0 | |
| 111811449 | 11181144 | 8 | 20151008 | 20151022 | 0 | |
| 111811449 | 11181144 | 9 | 20080313 | 0 | ||
| 111811449 | 11181144 | 11 | 20150422 | 20150428 | 0 | |
| 111811449 | 11181144 | 12 | 20150422 | 20150428 | 0 | |
| 111811449 | 11181144 | 17 | 20150422 | 20150428 | 0 | |
| 111811449 | 11181144 | 22 | 20150422 | 20150428 | 0 |