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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127001801 | 12700180 | 1 | I | 20160816 | 20160830 | 20160830 | EXP | US-SA-2016SA153181 | AVENTIS | MULL JL, MADDEN LM, BAYLISS SJ. MYELODYSPLASTIC SYNDROME OCCURRING IN A PATIENT WITH GORLIN SYNDROME. PEDIATRIC DERMATOLOGY. 2016;33(4):E256-7.DOI:10.1111/PDE.12880 | 8.00 | YR | C | M | Y | 0.00000 | 20160830 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127001801 | 12700180 | 1 | PS | THYMOGLOBULIN | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | UNKNOWN | 103869 | ||||||||||
| 127001801 | 12700180 | 2 | SS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 127001801 | 12700180 | 3 | SS | VINCRISTINE SULFATE. | VINCRISTINE SULFATE | 1 | Unknown | UNK | 0 | ||||||||||
| 127001801 | 12700180 | 4 | SS | LOMUSTINE. | LOMUSTINE | 1 | Unknown | UNK | 0 | ||||||||||
| 127001801 | 12700180 | 5 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK | 0 | ||||||||||
| 127001801 | 12700180 | 6 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 127001801 | 12700180 | 7 | SS | MELPHALAN | MELPHALAN | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 127001801 | 12700180 | 8 | C | TACROLIMUS. | TACROLIMUS | 1 | 0 | ||||||||||||
| 127001801 | 12700180 | 9 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 0 | ||||||||||||
| 127001801 | 12700180 | 10 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 127001801 | 12700180 | 11 | C | SIROLIMUS. | SIROLIMUS | 1 | 0 | ||||||||||||
| 127001801 | 12700180 | 12 | C | MESNA. | MESNA | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127001801 | 12700180 | 1 | Bone marrow conditioning regimen |
| 127001801 | 12700180 | 2 | Bone marrow conditioning regimen |
| 127001801 | 12700180 | 3 | Medulloblastoma |
| 127001801 | 12700180 | 4 | Medulloblastoma |
| 127001801 | 12700180 | 5 | Medulloblastoma |
| 127001801 | 12700180 | 6 | Medulloblastoma |
| 127001801 | 12700180 | 7 | Bone marrow conditioning regimen |
| 127001801 | 12700180 | 12 | Medulloblastoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127001801 | 12700180 | OT |
| 127001801 | 12700180 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127001801 | 12700180 | Adenovirus infection | |
| 127001801 | 12700180 | BK virus infection | |
| 127001801 | 12700180 | Graft versus host disease | |
| 127001801 | 12700180 | Infection | |
| 127001801 | 12700180 | Myelodysplastic syndrome | |
| 127001801 | 12700180 | Off label use | |
| 127001801 | 12700180 | Pancytopenia | |
| 127001801 | 12700180 | Sepsis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |