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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126134191 | 12613419 | 1 | I | 20160720 | 20160802 | 20160802 | EXP | US-APOTEX-2016AP010054 | APOTEX | BOULL CL, HYLWA SA, SAJIC D, WAGNER JE, TOLAR J, HOOK KP.. TOXIC EPIDERMAL NECROLYSIS IN RECESSIVE DYSTROPHIC EPIDERMOLYSIS BULLOSA FOLLOWING BONE MARROW TRANSPLANTATION.. J-PEDIATR. 2016;173:242-244 | 3.00 | YR | M | Y | 0.00000 | 20160802 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126134191 | 12613419 | 1 | PS | LEVOFLOXACIN TABLETS | LEVOFLOXACIN | 1 | Unknown | Y | 90787 | TABLET | |||||||||
| 126134191 | 12613419 | 2 | SS | CEFAZOLIN | CEFAZOLIN | 1 | Unknown | Y | U | 0 | |||||||||
| 126134191 | 12613419 | 3 | SS | CEFTAZIDIME. | CEFTAZIDIME | 1 | Unknown | Y | U | 0 | |||||||||
| 126134191 | 12613419 | 4 | SS | CEFTAZIDIME. | CEFTAZIDIME | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 126134191 | 12613419 | 5 | SS | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | Unknown | Y | U | 0 | |||||||||
| 126134191 | 12613419 | 6 | SS | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 126134191 | 12613419 | 7 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Unknown | Y | U | 0 | |||||||||
| 126134191 | 12613419 | 8 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 126134191 | 12613419 | 9 | SS | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | Y | U | 0 | |||||||||
| 126134191 | 12613419 | 10 | C | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | UNK | 0 | ||||||||||
| 126134191 | 12613419 | 11 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | Y | 0 | ||||||||||
| 126134191 | 12613419 | 12 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Other | 0 | |||||||||||
| 126134191 | 12613419 | 13 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Other | 0 | |||||||||||
| 126134191 | 12613419 | 14 | C | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Other | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126134191 | 12613419 | 1 | Product used for unknown indication |
| 126134191 | 12613419 | 2 | Product used for unknown indication |
| 126134191 | 12613419 | 3 | Product used for unknown indication |
| 126134191 | 12613419 | 5 | Product used for unknown indication |
| 126134191 | 12613419 | 7 | Product used for unknown indication |
| 126134191 | 12613419 | 9 | Prophylaxis |
| 126134191 | 12613419 | 10 | Prophylaxis against graft versus host disease |
| 126134191 | 12613419 | 11 | Prophylaxis against graft versus host disease |
| 126134191 | 12613419 | 12 | Bone marrow conditioning regimen |
| 126134191 | 12613419 | 13 | Bone marrow conditioning regimen |
| 126134191 | 12613419 | 14 | Bone marrow conditioning regimen |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126134191 | 12613419 | HO |
| 126134191 | 12613419 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126134191 | 12613419 | Electrolyte imbalance | |
| 126134191 | 12613419 | Pancytopenia | |
| 126134191 | 12613419 | Toxic epidermal necrolysis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |