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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 87677972 | 8767797 | 2 | F | 20110928 | 20131211 | 20120905 | 20160722 | EXP | DE-ROCHE-1113050 | ROCHE | 19.58 | YR | M | Y | 97.90000 | KG | 20160722 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 87677972 | 8767797 | 1 | PS | VALGANCICLOVIR. | VALGANCICLOVIR | 1 | Unknown | U | 21304 | 450 | MG | ||||||||
| 87677972 | 8767797 | 2 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Oral | DATE OF LAST DOSE PRIOR TO SAE: 28/SEP/2011 | U | 0 | 5 | MG | QD | ||||||
| 87677972 | 8767797 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | DRUG: TACROLIMUS PROGRAF, DATE OF LAST DOSE PRIOR TO SAE: 28/SEP/2011 | U | 0 | 3 | MG | QD | ||||||
| 87677972 | 8767797 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | U | 50722 | ||||||||||
| 87677972 | 8767797 | 5 | C | CANDIO HERMAL | 2 | Oral | DOSE: 3X1 PIP, DATE OF LAST DOSE PRIOR TO SAE: 28/SEP/2011 | 0 | QD | ||||||||||
| 87677972 | 8767797 | 6 | C | CANDIO HERMAL | 2 | Oral | DOSE: 3X1 PIP, DATE OF LAST DOSE PRIOR TO SAE: 28/SEP/2011, DRUG INDICATION: APHTHEN | 0 | QD | ||||||||||
| 87677972 | 8767797 | 7 | C | ROCEPHIN | CEFTRIAXONE SODIUM | 1 | Oral | DATE OF LAST DOSE PRIOR TO SAE: 28/SEP/2011 | 0 | 20 | ML | QD | |||||||
| 87677972 | 8767797 | 8 | C | BICANORM | SODIUM BICARBONATE | 1 | Oral | DATE OF LAST DOSE PRIOR TO SAE: 28/SEP/2011 | 0 | 2 | G | QD | |||||||
| 87677972 | 8767797 | 9 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Oral | DATE OF LAST DOSE PRIOR TO SAE: 28/SEP/2011 | 0 | 150 | MG | QD | |||||||
| 87677972 | 8767797 | 10 | C | VIGANTOLETTEN | CHOLECALCIFEROL | 1 | Oral | DOSE: 2000E, DATE OF LAST DOSE PRIOR TO SAE: 28/SEP/2011 | 0 | QD | |||||||||
| 87677972 | 8767797 | 11 | C | FORTUM | CEFTAZIDIME | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE: 28/SEP/2011 | 0 | 5 | MG | QD | |||||||
| 87677972 | 8767797 | 12 | C | AMPICILLIN | AMPICILLIN | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE: 28/SEP/2011 | 0 | 9 | G | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 87677972 | 8767797 | 1 | Infection in an immunocompromised host |
| 87677972 | 8767797 | 2 | Prophylaxis against transplant rejection |
| 87677972 | 8767797 | 3 | Prophylaxis against transplant rejection |
| 87677972 | 8767797 | 4 | Product used for unknown indication |
| 87677972 | 8767797 | 5 | Prophylaxis |
| 87677972 | 8767797 | 7 | Prophylaxis |
| 87677972 | 8767797 | 8 | Metabolic acidosis |
| 87677972 | 8767797 | 9 | Prophylaxis |
| 87677972 | 8767797 | 10 | Hyperparathyroidism secondary |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 87677972 | 8767797 | HO |
| 87677972 | 8767797 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 87677972 | 8767797 | Acne | |
| 87677972 | 8767797 | Agranulocytosis | |
| 87677972 | 8767797 | BK virus infection | |
| 87677972 | 8767797 | Epstein-Barr virus infection | |
| 87677972 | 8767797 | Hyperparathyroidism secondary | |
| 87677972 | 8767797 | Leukopenia | |
| 87677972 | 8767797 | Metabolic acidosis | |
| 87677972 | 8767797 | Viral sepsis |
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 |
|---|---|---|---|---|---|---|
| 87677972 | 8767797 | 2 | 20110613 | 0 | ||
| 87677972 | 8767797 | 3 | 20110617 | 0 | ||
| 87677972 | 8767797 | 5 | 20110613 | 0 | ||
| 87677972 | 8767797 | 6 | 20110928 | 0 | ||
| 87677972 | 8767797 | 7 | 20110613 | 0 | ||
| 87677972 | 8767797 | 8 | 20110707 | 0 | ||
| 87677972 | 8767797 | 9 | 20110721 | 0 | ||
| 87677972 | 8767797 | 10 | 20110831 | 0 | ||
| 87677972 | 8767797 | 11 | 20110928 | 0 | ||
| 87677972 | 8767797 | 12 | 20110928 | 0 |