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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127172342 | 12717234 | 2 | F | 20160901 | 20160906 | 20160907 | EXP | PHHY2016FR119878 | SANDOZ | CERAULO A, MALCUS C, DURANDY A, PICARD C, BERTRAND Y. ACTIVATED PI3-KINASE DELTA SYNDROME: LONG-TERM FOLLOW-UP AFTER CORD BLOOD TRANSPLANTATION. JOURNAL OF CLINICAL IMMUNOLOGY. 2016;36:544-6 | 0.00 | M | Y | 0.00000 | 20160907 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127172342 | 12717234 | 1 | PS | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | UNK | 65017 | ||||||||||
| 127172342 | 12717234 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | 65017 | ||||||||||||
| 127172342 | 12717234 | 3 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | UNK | 0 | ||||||||||
| 127172342 | 12717234 | 4 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | 0 | ||||||||||||
| 127172342 | 12717234 | 5 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 30 MG/M2, QD (D-8 TO D-4)) | 0 | 30 | MG/M**2 | QD | |||||||
| 127172342 | 12717234 | 6 | C | MELPHALAN | MELPHALAN | 1 | Unknown | 70 MG/M2, QD (AT D-3 AND D-2) | 0 | 70 | MG/M**2 | QD | |||||||
| 127172342 | 12717234 | 7 | C | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Unknown | 2.5 MG/KG, QD ((FROM D-2 TO D +2) | 0 | 2.5 | MG/KG | QD | |||||||
| 127172342 | 12717234 | 8 | C | COTRIMOXAZOLE | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | UNK | 0 | ||||||||||
| 127172342 | 12717234 | 9 | C | CIDOFOVIR. | CIDOFOVIR | 1 | Unknown | 5 MG/KG, QW | 0 | 5 | MG/KG | /wk | |||||||
| 127172342 | 12717234 | 10 | C | RITUXIMAB | RITUXIMAB | 1 | Unknown | 375 MG/M2, QW | 0 | 375 | MG/M**2 | /wk | |||||||
| 127172342 | 12717234 | 11 | C | GRANULOCYTE COLONY STIMULATING FACTOR | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | 5 UG/KG, QD | 0 | QD | |||||||||
| 127172342 | 12717234 | 12 | C | NITAZOXANIDE | NITAZOXANIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 127172342 | 12717234 | 13 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127172342 | 12717234 | 1 | Stem cell transplant |
| 127172342 | 12717234 | 2 | Prophylaxis against graft versus host disease |
| 127172342 | 12717234 | 3 | Stem cell transplant |
| 127172342 | 12717234 | 4 | Prophylaxis against graft versus host disease |
| 127172342 | 12717234 | 5 | Bone marrow conditioning regimen |
| 127172342 | 12717234 | 6 | Bone marrow conditioning regimen |
| 127172342 | 12717234 | 7 | Bone marrow conditioning regimen |
| 127172342 | 12717234 | 8 | Infection prophylaxis |
| 127172342 | 12717234 | 9 | Infection prophylaxis |
| 127172342 | 12717234 | 10 | Infection prophylaxis |
| 127172342 | 12717234 | 11 | Infection prophylaxis |
| 127172342 | 12717234 | 12 | Cryptosporidiosis infection |
| 127172342 | 12717234 | 13 | Cryptosporidiosis infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127172342 | 12717234 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127172342 | 12717234 | Acute graft versus host disease | |
| 127172342 | 12717234 | Engraftment syndrome | |
| 127172342 | 12717234 | Enteritis | |
| 127172342 | 12717234 | Pyrexia | |
| 127172342 | 12717234 | Rash | |
| 127172342 | 12717234 | Weight increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |