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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126901872 | 12690187 | 2 | F | 201606 | 20160920 | 20160826 | 20160922 | EXP | US-JNJFOC-20160820972 | JANSSEN | 7.80 | YR | C | M | Y | 15.88000 | KG | 20160922 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126901872 | 12690187 | 1 | PS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | N | UNKNOWN | 21121 | SUSTAINED RELEASE TABLETS | ||||||||
| 126901872 | 12690187 | 2 | C | TACROLIMUS. | TACROLIMUS | 1 | Oral | D | 0 | TABLET | |||||||||
| 126901872 | 12690187 | 3 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | D | 0 | TABLET | |||||||||
| 126901872 | 12690187 | 4 | C | ENALAPRIL | ENALAPRIL | 1 | Oral | D | 0 | 5 | MG | TABLET | BID | ||||||
| 126901872 | 12690187 | 5 | C | EVEROLIMUS | EVEROLIMUS | 1 | Oral | D | 0 | TABLET | |||||||||
| 126901872 | 12690187 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Oral | D | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126901872 | 12690187 | 1 | Attention deficit/hyperactivity disorder |
| 126901872 | 12690187 | 2 | Prophylaxis against transplant rejection |
| 126901872 | 12690187 | 3 | Prophylaxis against transplant rejection |
| 126901872 | 12690187 | 4 | Cardiac disorder |
| 126901872 | 12690187 | 5 | Prophylaxis against transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126901872 | 12690187 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126901872 | 12690187 | Abnormal behaviour | |
| 126901872 | 12690187 | Agitation | |
| 126901872 | 12690187 | Anxiety | |
| 126901872 | 12690187 | Blood magnesium decreased | |
| 126901872 | 12690187 | Cardiomyopathy | |
| 126901872 | 12690187 | Heart transplant rejection | |
| 126901872 | 12690187 | Hypotension | |
| 126901872 | 12690187 | Malaise | |
| 126901872 | 12690187 | Mood altered | |
| 126901872 | 12690187 | Mood swings |
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 |
|---|---|---|---|---|---|---|
| 126901872 | 12690187 | 1 | 201510 | 0 | ||
| 126901872 | 12690187 | 2 | 201308 | 0 | ||
| 126901872 | 12690187 | 3 | 201308 | 0 | ||
| 126901872 | 12690187 | 4 | 201607 | 0 | ||
| 126901872 | 12690187 | 5 | 201606 | 0 | ||
| 126901872 | 12690187 | 6 | 201606 | 0 |