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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124450604 | 12445060 | 4 | F | 20160824 | 20160607 | 20160830 | EXP | PHHY2016US077860 | SANDOZ | 10.00 | YR | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124450604 | 12445060 | 1 | PS | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | UNK | 65017 | ||||||||||
| 124450604 | 12445060 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | 65017 | ||||||||||||
| 124450604 | 12445060 | 3 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | UNK | 0 | ||||||||||
| 124450604 | 12445060 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 0 | ||||||||||||
| 124450604 | 12445060 | 5 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | UNK | 0 | ||||||||||
| 124450604 | 12445060 | 6 | C | TREOSULFAN | TREOSULFAN | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124450604 | 12445060 | 1 | Cord blood transplant therapy |
| 124450604 | 12445060 | 2 | Prophylaxis against graft versus host disease |
| 124450604 | 12445060 | 3 | Cord blood transplant therapy |
| 124450604 | 12445060 | 4 | Prophylaxis against graft versus host disease |
| 124450604 | 12445060 | 5 | Bone marrow conditioning regimen |
| 124450604 | 12445060 | 6 | Bone marrow conditioning regimen |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124450604 | 12445060 | HO |
| 124450604 | 12445060 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124450604 | 12445060 | Acute left ventricular failure | |
| 124450604 | 12445060 | Cardiac failure | |
| 124450604 | 12445060 | Cough | |
| 124450604 | 12445060 | Disease progression | |
| 124450604 | 12445060 | Lower respiratory tract infection | |
| 124450604 | 12445060 | Multiple organ dysfunction syndrome | |
| 124450604 | 12445060 | Nasal congestion | |
| 124450604 | 12445060 | Pulmonary oedema | |
| 124450604 | 12445060 | Respiratory distress | |
| 124450604 | 12445060 | Rhinovirus infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |