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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103919162 | 10391916 | 2 | F | 20151221 | 20140819 | 20151231 | EXP | PHHY2014IN101829 | NOVARTIS | JAISWAL SR, CHATTERJEE S, CHAKRABARTI S.. PATERNAL BONE MARROW INFUSION AS SALVAGE THERAPY FOR SEVERE GVHD FOLLOWING MATERNAL HAPLOIDENTICAL TRANSPLANTATION RESULTING IN BIPARENTAL CHIMERISM. INTERNATIONAL JOURNAL OF HEMATOLOGY. 2013?98(4):504-8 | 3.00 | YR | M | Y | 0.00000 | 20160101 | OT | IN | IN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103919162 | 10391916 | 1 | PS | CICLOSPORIN | CYCLOSPORINE | 1 | 50574 | ||||||||||||
| 103919162 | 10391916 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | 50574 | ||||||||||||
| 103919162 | 10391916 | 3 | SS | MYCOPHENOLIC ACID. | MYCOPHENOLIC ACID | 1 | Unknown | 0 | |||||||||||
| 103919162 | 10391916 | 4 | SS | MYCOPHENOLIC ACID. | MYCOPHENOLIC ACID | 1 | 0 | ||||||||||||
| 103919162 | 10391916 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | |||||||||||
| 103919162 | 10391916 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | 0 | ||||||||||||
| 103919162 | 10391916 | 7 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 0.5 MG/KG, UNK | 0 | .5 | MG/KG | ||||||||
| 103919162 | 10391916 | 8 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | 0 | ||||||||||||
| 103919162 | 10391916 | 9 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 50 MG/KG, PER DAY | 0 | 50 | MG/KG | ||||||||
| 103919162 | 10391916 | 10 | SS | INFLIXIMAB | INFLIXIMAB | 1 | Unknown | 5 MG/KG, UNK | 0 | 5 | MG/KG | ||||||||
| 103919162 | 10391916 | 11 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 0 | |||||||||||
| 103919162 | 10391916 | 12 | C | TREOSULFAN | TREOSULFAN | 1 | Unknown | 0 | |||||||||||
| 103919162 | 10391916 | 13 | C | THIOTEPA. | THIOTEPA | 1 | Unknown | 0 | |||||||||||
| 103919162 | 10391916 | 14 | C | ETANERCEPT | ETANERCEPT | 1 | Unknown | 0 | |||||||||||
| 103919162 | 10391916 | 15 | C | SIROLIMUS. | SIROLIMUS | 1 | Unknown | 0 | |||||||||||
| 103919162 | 10391916 | 16 | C | CAMPATH | ALEMTUZUMAB | 1 | Unknown | 0.2 MG/KG, UNK | 0 | .2 | MG/KG | ||||||||
| 103919162 | 10391916 | 17 | C | CAMPATH | ALEMTUZUMAB | 1 | Unknown | 10 MG, UNK | 0 | 10 | MG | ||||||||
| 103919162 | 10391916 | 18 | C | BUDESONIDE. | BUDESONIDE | 1 | Oral | 0 | |||||||||||
| 103919162 | 10391916 | 19 | C | ATGAM | EQUINE THYMOCYTE IMMUNE GLOBULIN | 1 | Unknown | 15 MG/KG, PER DAY | 0 | 15 | MG/KG | ||||||||
| 103919162 | 10391916 | 20 | C | FOSCARNET | FOSCARNET | 1 | Unknown | 0 | |||||||||||
| 103919162 | 10391916 | 21 | C | IMMUNOGLOBULIN I.V | HUMAN IMMUNOGLOBULIN G | 1 | Oral | 0 | |||||||||||
| 103919162 | 10391916 | 22 | C | IMMUNOGLOBULIN I.V | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103919162 | 10391916 | 1 | Stem cell transplant |
| 103919162 | 10391916 | 2 | Prophylaxis against graft versus host disease |
| 103919162 | 10391916 | 3 | Stem cell transplant |
| 103919162 | 10391916 | 4 | Prophylaxis against graft versus host disease |
| 103919162 | 10391916 | 5 | Stem cell transplant |
| 103919162 | 10391916 | 6 | Prophylaxis against graft versus host disease |
| 103919162 | 10391916 | 7 | Stem cell transplant |
| 103919162 | 10391916 | 8 | Prophylaxis against graft versus host disease |
| 103919162 | 10391916 | 9 | Prophylaxis against graft versus host disease |
| 103919162 | 10391916 | 10 | Graft versus host disease |
| 103919162 | 10391916 | 11 | Bone marrow conditioning regimen |
| 103919162 | 10391916 | 12 | Bone marrow conditioning regimen |
| 103919162 | 10391916 | 13 | Bone marrow conditioning regimen |
| 103919162 | 10391916 | 14 | Product used for unknown indication |
| 103919162 | 10391916 | 15 | Product used for unknown indication |
| 103919162 | 10391916 | 16 | Product used for unknown indication |
| 103919162 | 10391916 | 18 | Product used for unknown indication |
| 103919162 | 10391916 | 19 | Product used for unknown indication |
| 103919162 | 10391916 | 20 | Product used for unknown indication |
| 103919162 | 10391916 | 21 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103919162 | 10391916 | HO |
| 103919162 | 10391916 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103919162 | 10391916 | Diarrhoea | |
| 103919162 | 10391916 | Epstein-Barr virus infection | |
| 103919162 | 10391916 | Faecal volume increased | |
| 103919162 | 10391916 | Graft versus host disease in gastrointestinal tract | |
| 103919162 | 10391916 | Graft versus host disease in liver | |
| 103919162 | 10391916 | Hyperbilirubinaemia | |
| 103919162 | 10391916 | Jaundice | |
| 103919162 | 10391916 | Pneumonia cytomegaloviral | |
| 103919162 | 10391916 | Pyrexia | |
| 103919162 | 10391916 | Rash | |
| 103919162 | 10391916 | Respiratory distress | |
| 103919162 | 10391916 | Rotavirus infection | |
| 103919162 | 10391916 | Seizure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |