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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114236542 | 11423654 | 2 | F | 20120122 | 20160629 | 20150827 | 20160712 | PER | US-ALEXION-A201503257 | ALEXION | 0.00 | M | Y | 105.60000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114236542 | 11423654 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | FOUR DOSES 900MG + 300MG, QW | T3-AD7698B02 | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||||
| 114236542 | 11423654 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, SINGLE | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | ||||||
| 114236542 | 11423654 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 114236542 | 11423654 | 4 | C | AMOXICILLIN. | AMOXICILLIN | 1 | Oral | 500 MG, QD | 0 | 500 | MG | CAPSULE | QD | ||||||
| 114236542 | 11423654 | 5 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | CAPSULE | QD | ||||||
| 114236542 | 11423654 | 6 | C | ATARAX | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Oral | 25 MG, TID, PRN | 0 | 25 | MG | TABLET | TID | ||||||
| 114236542 | 11423654 | 7 | C | RENVELA | SEVELAMER CARBONATE | 1 | Oral | 800 MG, TID, WITH MEALS | 0 | 800 | MG | TABLET | TID | ||||||
| 114236542 | 11423654 | 8 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | UNK, Q6H, PRN | 0 | Q6H | |||||||||
| 114236542 | 11423654 | 9 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | 0 | |||||||||||
| 114236542 | 11423654 | 10 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 114236542 | 11423654 | 11 | C | ROBITUSSIN (GUAIFENESIN) | GUAIFENESIN | 1 | Unknown | 0 | |||||||||||
| 114236542 | 11423654 | 12 | C | ROBITUSSIN (GUAIFENESIN) | GUAIFENESIN | 1 | 0 | ||||||||||||
| 114236542 | 11423654 | 13 | C | OSCAL | CALCIUM CARBONATE | 1 | Oral | 2500 MG, TID | 0 | 2500 | MG | TID | |||||||
| 114236542 | 11423654 | 14 | C | SEVELAMER | SEVELAMER | 1 | Oral | 800 MG, TID | 0 | 800 | MG | TID | |||||||
| 114236542 | 11423654 | 15 | C | ALBUTEROL /00139501/ | ALBUTEROL | 1 | Unknown | UNK, PRN | 0 | /yr | |||||||||
| 114236542 | 11423654 | 16 | C | OXYBUTYNIN | OXYBUTYNIN | 1 | Oral | 5 UNK, UNK | 0 | 5 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114236542 | 11423654 | 1 | Haemolytic uraemic syndrome |
| 114236542 | 11423654 | 4 | Prophylaxis |
| 114236542 | 11423654 | 5 | Attention deficit/hyperactivity disorder |
| 114236542 | 11423654 | 6 | Pruritus |
| 114236542 | 11423654 | 7 | Product used for unknown indication |
| 114236542 | 11423654 | 8 | Rash pruritic |
| 114236542 | 11423654 | 9 | Oropharyngeal pain |
| 114236542 | 11423654 | 10 | Cough |
| 114236542 | 11423654 | 11 | Cough |
| 114236542 | 11423654 | 12 | Nasal congestion |
| 114236542 | 11423654 | 13 | Hypocalcaemia |
| 114236542 | 11423654 | 14 | Hyperphosphataemia |
| 114236542 | 11423654 | 15 | Asthma |
| 114236542 | 11423654 | 16 | Urticaria |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114236542 | 11423654 | Complication associated with device | |
| 114236542 | 11423654 | Epistaxis | |
| 114236542 | 11423654 | Hypertension | |
| 114236542 | 11423654 | Incorrect dose administered | |
| 114236542 | 11423654 | Proteinuria |
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 |
|---|---|---|---|---|---|---|
| 114236542 | 11423654 | 1 | 20120122 | 0 | ||
| 114236542 | 11423654 | 2 | 20120206 | 0 | ||
| 114236542 | 11423654 | 3 | 201202 | 0 |