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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125789161 | 12578916 | 1 | I | 20160708 | 0 | 20160720 | 20160720 | DIR | 53.00 | YR | M | N | 0.00000 | 20160719 | Y | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125789161 | 12578916 | 1 | PS | CARMUSTINE | CARMUSTINE | 1 | D | D | 0 | ||||||||||
| 125789161 | 12578916 | 2 | SS | CYTARABINE. | CYTARABINE | 1 | D | D | 0 | ||||||||||
| 125789161 | 12578916 | 3 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | 0 | ||||||||||||
| 125789161 | 12578916 | 4 | SS | MELPHALAN | MELPHALAN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125789161 | 12578916 | 1 | Stem cell transplant |
| 125789161 | 12578916 | 2 | Plasma cell myeloma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125789161 | 12578916 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125789161 | 12578916 | Acute graft versus host disease | |
| 125789161 | 12578916 | Cardiac failure | |
| 125789161 | 12578916 | Delirium | |
| 125789161 | 12578916 | Encephalopathy | |
| 125789161 | 12578916 | Escherichia bacteraemia | |
| 125789161 | 12578916 | Graft versus host disease in gastrointestinal tract | |
| 125789161 | 12578916 | Graft versus host disease in skin | |
| 125789161 | 12578916 | Mucosal inflammation | |
| 125789161 | 12578916 | Septic shock | |
| 125789161 | 12578916 | Staphylococcal bacteraemia | |
| 125789161 | 12578916 | Urinary tract infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 125789161 | 12578916 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125789161 | 12578916 | 1 | 20160527 | 20160601 | 0 | |
| 125789161 | 12578916 | 2 | 20160603 | 20160603 | 0 |