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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117791614 | 11779161 | 4 | F | 20160915 | 20151117 | 20160922 | EXP | JP-JNJFOC-20151113697 | JANSSEN | TAKETANI T, OYAMA C, MIHARA A, TANABE Y, ABE M, HIRADE T, ET AL. EX VIVO EXPANDED ALLOGENEIC MESENCHYMAL STEM CELLS WITH BONE MARROW TRANSPLANTATION IMPROVED OSTEOGENESIS IN INFANTS WITH SEVERE HYPOPHOSPHATASIA. CELL TRANSPLANTATION 2015;24(10):1931-43. | 7.00 | MON | I | M | Y | 0.00000 | 20160922 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117791614 | 11779161 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 103772 | LYOPHILIZED POWDER | ||||||||
| 117791614 | 11779161 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 117791614 | 11779161 | 3 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 117791614 | 11779161 | 4 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117791614 | 11779161 | 1 | Acute graft versus host disease |
| 117791614 | 11779161 | 2 | Acute graft versus host disease |
| 117791614 | 11779161 | 3 | Chronic graft versus host disease |
| 117791614 | 11779161 | 4 | Acute graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117791614 | 11779161 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117791614 | 11779161 | Bronchomalacia | |
| 117791614 | 11779161 | Complex partial seizures | |
| 117791614 | 11779161 | Diarrhoea haemorrhagic | |
| 117791614 | 11779161 | Hypothyroidism | |
| 117791614 | 11779161 | Off label use | |
| 117791614 | 11779161 | Pneumonia | |
| 117791614 | 11779161 | Product use issue | |
| 117791614 | 11779161 | Respiratory distress |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |