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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118155922 | 11815592 | 2 | F | 200311 | 20160831 | 20151209 | 20160913 | EXP | JP-GILEAD-2015-0186192 | GILEAD | MINEMURA M., TOKIMITSU Y., TAJIRI K., NAKAYAMA Y., KAWAI K., KUDO H. ET AL.. DEVELOPMENT OF OSTEOMALACIA IN A POST-LIVER TRANSPLANT PATIENT RECEIVING ADEFOVIR DIPIVOXIL.. WORLD JOURNAL OF HEPATOLOGY. 2010;2 (12):442-446 | 48.00 | YR | A | M | Y | 0.00000 | 20160913 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118155922 | 11815592 | 1 | PS | ADEFOVIR DIPIVOXIL. | ADEFOVIR DIPIVOXIL | 1 | Oral | 10 MG, QD | Y | U | 21449 | 10 | MG | TABLET | QD | ||||
| 118155922 | 11815592 | 2 | I | ADEFOVIR DIPIVOXIL. | ADEFOVIR DIPIVOXIL | 1 | Oral | 10 MG, QOD | Y | U | 21449 | 10 | MG | TABLET | QOD | ||||
| 118155922 | 11815592 | 3 | I | ADEFOVIR DIPIVOXIL. | ADEFOVIR DIPIVOXIL | 1 | Oral | 5 MG, QOD | Y | U | 21449 | 5 | MG | TABLET | QOD | ||||
| 118155922 | 11815592 | 4 | I | ADEFOVIR DIPIVOXIL. | ADEFOVIR DIPIVOXIL | 1 | Oral | 2.5 MG, QD | Y | U | 21449 | 2.5 | MG | TABLET | QD | ||||
| 118155922 | 11815592 | 5 | I | TACROLIMUS. | TACROLIMUS | 1 | Unknown | U | U | 0 | |||||||||
| 118155922 | 11815592 | 6 | I | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 118155922 | 11815592 | 7 | SS | LAMIVUDINE. | LAMIVUDINE | 1 | Oral | 100 MG, QD | Y | U | 0 | 100 | MG | QD | |||||
| 118155922 | 11815592 | 8 | C | HEPATITIS B IMMUNE GLOBULIN | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 10000 IU, UNK | 0 | 10000 | IU | ||||||||
| 118155922 | 11815592 | 9 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 500 MG, QD | 0 | 500 | MG | QD | |||||||
| 118155922 | 11815592 | 10 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 500 MG, QD | 0 | 500 | MG | QD | |||||||
| 118155922 | 11815592 | 11 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 118155922 | 11815592 | 12 | C | PREDNISONE. | PREDNISONE | 1 | 2.5 UNK, UNK | 0 | 2.5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118155922 | 11815592 | 1 | Hepatitis B |
| 118155922 | 11815592 | 5 | Immunosuppression |
| 118155922 | 11815592 | 7 | Hepatic cirrhosis |
| 118155922 | 11815592 | 8 | Antiviral prophylaxis |
| 118155922 | 11815592 | 9 | Immunosuppression |
| 118155922 | 11815592 | 11 | Immunosuppression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118155922 | 11815592 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118155922 | 11815592 | Arthralgia | |
| 118155922 | 11815592 | Blood alkaline phosphatase increased | |
| 118155922 | 11815592 | Blood parathyroid hormone increased | |
| 118155922 | 11815592 | Bone pain | |
| 118155922 | 11815592 | Drug interaction | |
| 118155922 | 11815592 | Drug level increased | |
| 118155922 | 11815592 | Drug resistance | |
| 118155922 | 11815592 | Gait disturbance | |
| 118155922 | 11815592 | Hypophosphataemia | |
| 118155922 | 11815592 | Muscular weakness | |
| 118155922 | 11815592 | Musculoskeletal pain | |
| 118155922 | 11815592 | Osteomalacia | |
| 118155922 | 11815592 | Renal failure | |
| 118155922 | 11815592 | Renal salt-wasting syndrome | |
| 118155922 | 11815592 | Renal tubular dysfunction |
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 |
|---|---|---|---|---|---|---|
| 118155922 | 11815592 | 1 | 200203 | 0 | ||
| 118155922 | 11815592 | 7 | 200001 | 0 |