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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125575852 | 12557585 | 2 | F | 20160104 | 20160715 | 20160714 | 20160715 | EXP | CN-PFIZER INC-2016338902 | PFIZER | 58.00 | YR | M | Y | 0.00000 | 20160715 | OT | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125575852 | 12557585 | 1 | PS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous drip | 500 MG, 1X/DAY | 1000 | MG | Y | J29457 | 11856 | 500 | MG | POWDER FOR SOLUTION FOR INJECTION | QD | ||
| 125575852 | 12557585 | 2 | SS | PROPOFOL. | PROPOFOL | 1 | Intravenous (not otherwise specified) | UNK,INJECTION 3ML | U | 77908 | EMULSION FOR INJECTION | ||||||||
| 125575852 | 12557585 | 3 | SS | PROPOFOL. | PROPOFOL | 1 | U | 77908 | EMULSION FOR INJECTION | ||||||||||
| 125575852 | 12557585 | 4 | SS | DIAZEPAM. | DIAZEPAM | 1 | Intravenous (not otherwise specified) | 10 MG, UNK | U | 0 | 10 | MG | |||||||
| 125575852 | 12557585 | 5 | SS | DIAZEPAM. | DIAZEPAM | 1 | U | 0 | |||||||||||
| 125575852 | 12557585 | 6 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | 4.5 MG, 2X/DAY | 1E2080A | 0 | 4.5 | MG | BID | ||||||
| 125575852 | 12557585 | 7 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 1 G, 2X/DAY | 150908 | 0 | 1 | G | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125575852 | 12557585 | 1 | Transplant rejection |
| 125575852 | 12557585 | 2 | Mania |
| 125575852 | 12557585 | 3 | Delirium |
| 125575852 | 12557585 | 4 | Mania |
| 125575852 | 12557585 | 5 | Delirium |
| 125575852 | 12557585 | 6 | Transplant rejection |
| 125575852 | 12557585 | 7 | Transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125575852 | 12557585 | OT |
| 125575852 | 12557585 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125575852 | 12557585 | Aggression | |
| 125575852 | 12557585 | Delirium | |
| 125575852 | 12557585 | Drug ineffective | |
| 125575852 | 12557585 | Mania | |
| 125575852 | 12557585 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125575852 | 12557585 | 1 | 20160101 | 20160102 | 0 | |
| 125575852 | 12557585 | 6 | 20160102 | 20160102 | 0 | |
| 125575852 | 12557585 | 7 | 20160102 | 20160102 | 0 |