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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127076081 | 12707608 | 1 | I | 20160329 | 20160331 | 20160901 | 20160901 | EXP | PHHO2016US004898 | SANDOZ | 30.46 | YR | F | Y | 74.60000 | KG | 20160901 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127076081 | 12707608 | 1 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 0.5 MG, QOD | 0 | .5 | MG | ||||||||
| 127076081 | 12707608 | 2 | PS | PREDNISONE. | PREDNISONE | 1 | Oral | 40 MG, QD | 80336 | 40 | MG | QD | |||||||
| 127076081 | 12707608 | 3 | SS | BLINDED CSJ148 | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | SOLUTION FOR INFUSION | |||||||||
| 127076081 | 12707608 | 4 | SS | BLINDED NO TREATMENT RECEIVED | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | SOLUTION FOR INFUSION | |||||||||
| 127076081 | 12707608 | 5 | SS | BLINDED PLACEBO | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | SOLUTION FOR INFUSION | |||||||||
| 127076081 | 12707608 | 6 | SS | MAGNESIUM AMINO ACID CHELATE | MAGNESIUM | 1 | Oral | 266 MG, BID | 0 | 266 | MG | BID | |||||||
| 127076081 | 12707608 | 7 | SS | PREVPAC | AMOXICILLINCLARITHROMYCINLANSOPRAZOLE | 1 | Oral | 1030 MG, QD (500-500-30 MG) | 3090 | MG | 0 | 1030 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127076081 | 12707608 | 1 | Graft versus host disease |
| 127076081 | 12707608 | 2 | Graft versus host disease |
| 127076081 | 12707608 | 3 | Cytomegalovirus infection |
| 127076081 | 12707608 | 4 | Cytomegalovirus infection |
| 127076081 | 12707608 | 5 | Cytomegalovirus infection |
| 127076081 | 12707608 | 6 | Product used for unknown indication |
| 127076081 | 12707608 | 7 | Evidence based treatment |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127076081 | 12707608 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127076081 | 12707608 | Chest pain | |
| 127076081 | 12707608 | Nausea | |
| 127076081 | 12707608 | Upper respiratory tract infection | |
| 127076081 | 12707608 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127076081 | 12707608 | 1 | 20160723 | 0 | ||
| 127076081 | 12707608 | 2 | 20160708 | 0 | ||
| 127076081 | 12707608 | 3 | 20160217 | 0 | ||
| 127076081 | 12707608 | 4 | 20160217 | 0 | ||
| 127076081 | 12707608 | 5 | 20160217 | 0 | ||
| 127076081 | 12707608 | 6 | 20160325 | 0 | ||
| 127076081 | 12707608 | 7 | 20160422 | 20160424 | 0 |