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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127940091 | 12794009 | 1 | I | 20160922 | 20160929 | 20160929 | EXP | PHHY2016US131385 | NOVARTIS | SINGH AK, PORRATA LF, LIN T, SHUNE L, GANGULY S, MCGUIRK JP ET AL.. FATAL GVHD INDUCED BY PD-1 INHIBITOR PEMBROLIZUMAB IN A PATIENT WITH HODGKIN^S LYMPHOMA. BONE MARROW TRANSPLANTATION. 2016;51 (9):1268-70 | 29.00 | YR | M | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127940091 | 12794009 | 1 | PS | BASILIXIMAB | BASILIXIMAB | 1 | Unknown | U | 103764 | ||||||||||
| 127940091 | 12794009 | 2 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 2 MG/KG, UNK | U | 0 | 2 | MG/KG | |||||||
| 127940091 | 12794009 | 3 | SS | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127940091 | 12794009 | 1 | Acute graft versus host disease |
| 127940091 | 12794009 | 2 | Acute graft versus host disease |
| 127940091 | 12794009 | 3 | Acute graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127940091 | 12794009 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127940091 | 12794009 | Coagulopathy | |
| 127940091 | 12794009 | Disease progression | |
| 127940091 | 12794009 | Drug ineffective | |
| 127940091 | 12794009 | Graft versus host disease | |
| 127940091 | 12794009 | Hepatic failure | |
| 127940091 | 12794009 | Mental status changes | |
| 127940091 | 12794009 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |