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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126951921 | 12695192 | 1 | I | 20160824 | 20160829 | 20160829 | EXP | KR-JNJFOC-20160822780 | JANSSEN | KIM SJ, KIM WS, KANG HJ, KIM JS, CHOI CW, LEE SI, ET AL. SAFETY, PHARMACOKINETIC/PHARMACODYNAMIC PROFILES AND EFFICACY OF SAIT101, A BIOSIMILAR OF RITUXIMAB IN PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA. HAEMATOLOGICA 2012;97:317-318. | 0.00 | Y | 0.00000 | 20160829 | OT | KR | KR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126951921 | 12695192 | 1 | PS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | U | U | 50718 | LIPOSOME INJECTION | ||||||||
| 126951921 | 12695192 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 126951921 | 12695192 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 126951921 | 12695192 | 4 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 126951921 | 12695192 | 5 | SS | MABTHERA | RITUXIMAB | 1 | Unknown | U | 0 | 375 | MG/M**2 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126951921 | 12695192 | 1 | Diffuse large B-cell lymphoma |
| 126951921 | 12695192 | 2 | Diffuse large B-cell lymphoma |
| 126951921 | 12695192 | 3 | Diffuse large B-cell lymphoma |
| 126951921 | 12695192 | 4 | Diffuse large B-cell lymphoma |
| 126951921 | 12695192 | 5 | Diffuse large B-cell lymphoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126951921 | 12695192 | OT |
| 126951921 | 12695192 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126951921 | 12695192 | Decreased appetite | |
| 126951921 | 12695192 | Dyspepsia | |
| 126951921 | 12695192 | Fatigue | |
| 126951921 | 12695192 | Nausea | |
| 126951921 | 12695192 | Neutropenia | |
| 126951921 | 12695192 | Off label use | |
| 126951921 | 12695192 | Pneumonitis | |
| 126951921 | 12695192 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |