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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124617852 | 12461785 | 2 | F | 20160412 | 20160719 | 20160613 | 20160728 | EXP | TR-SA-2016SA109811 | AVENTIS | 9.00 | MON | I | F | Y | 8.00000 | KG | 20160728 | CN | TR | TR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124617852 | 12461785 | 1 | PS | CAMPATH | ALEMTUZUMAB | 1 | Unknown | F3012H01 | 103948 | .2 | MG/KG | QD | |||||||
| 124617852 | 12461785 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | N | UNKNOWN | 0 | |||||||||
| 124617852 | 12461785 | 3 | C | ENALAPRIL | ENALAPRIL | 1 | Oral | 0 | .3 | MG/KG | QD | ||||||||
| 124617852 | 12461785 | 4 | C | AMLODIPIN | AMLODIPINE BESYLATE | 1 | Oral | 0 | .5 | MG/KG | QD | ||||||||
| 124617852 | 12461785 | 5 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 0 | |||||||||||
| 124617852 | 12461785 | 6 | C | ECULIZUMAB | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 0 | 300 | MG | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124617852 | 12461785 | 1 | Combined immunodeficiency |
| 124617852 | 12461785 | 2 | Graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124617852 | 12461785 | HO |
| 124617852 | 12461785 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124617852 | 12461785 | Acute kidney injury | |
| 124617852 | 12461785 | Haematuria | |
| 124617852 | 12461785 | Haemolysis | |
| 124617852 | 12461785 | Hypertension | |
| 124617852 | 12461785 | Kidney enlargement | |
| 124617852 | 12461785 | Microangiopathy | |
| 124617852 | 12461785 | Oedema | |
| 124617852 | 12461785 | Oliguria | |
| 124617852 | 12461785 | Rash |
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 |
|---|---|---|---|---|---|---|
| 124617852 | 12461785 | 1 | 20160308 | 20160310 | 0 | |
| 124617852 | 12461785 | 2 | 20160418 | 20160425 | 0 |