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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125818371 | 12581837 | 1 | I | 20160215 | 20160722 | 20160722 | EXP | US-STRIDES ARCOLAB LIMITED-2016SP000959 | STRIDES | STEFANSKI HE, THIBERT KA, PRITCHETT J, PRUSTY BK, WAGNER JE, LUND TC. FATAL MYOCARDITIS ASSOCIATED WITH HHV-6 FOLLOWING IMMUNOSUPPRESSION IN TWO CHILDREN. PEDIATRICS. 2016;137(1):1-4 | 0.00 | Y | 0.00000 | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125818371 | 12581837 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | UNK | 90055 | |||||||||||
| 125818371 | 12581837 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | UNK | 0 | |||||||||||
| 125818371 | 12581837 | 3 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | UNK | 0 | |||||||||||
| 125818371 | 12581837 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | UNK | 0 | |||||||||||
| 125818371 | 12581837 | 5 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 48 MG/M2, UNK | 0 | 48 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125818371 | 12581837 | 1 | Prophylaxis against graft versus host disease |
| 125818371 | 12581837 | 2 | Prophylaxis against graft versus host disease |
| 125818371 | 12581837 | 3 | Cord blood transplant therapy |
| 125818371 | 12581837 | 4 | Cord blood transplant therapy |
| 125818371 | 12581837 | 5 | Acute graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125818371 | 12581837 | OT |
| 125818371 | 12581837 | HO |
| 125818371 | 12581837 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125818371 | 12581837 | Acute respiratory failure | |
| 125818371 | 12581837 | Dermatitis exfoliative | |
| 125818371 | 12581837 | Drug ineffective | |
| 125818371 | 12581837 | Ejection fraction decreased | |
| 125818371 | 12581837 | Human herpesvirus 6 infection | |
| 125818371 | 12581837 | Hypotension | |
| 125818371 | 12581837 | Hypoxia | |
| 125818371 | 12581837 | Lacrimation increased | |
| 125818371 | 12581837 | Nasal congestion | |
| 125818371 | 12581837 | Pyrexia | |
| 125818371 | 12581837 | Rales | |
| 125818371 | 12581837 | Rash maculo-papular | |
| 125818371 | 12581837 | Tachycardia | |
| 125818371 | 12581837 | Urine output decreased | |
| 125818371 | 12581837 | Viral myocarditis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |