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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126891062 | 12689106 | 2 | F | 20160916 | 20160826 | 20160928 | EXP | TW-CIPLA LTD.-2016TW17491 | CIPLA | 0.00 | Y | 0.00000 | 20160928 | OT | TW | TW |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126891062 | 12689106 | 1 | PS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | UNK, 3 CYCLES | U | U | 78759 | ||||||||
| 126891062 | 12689106 | 2 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | UNK | D | 0 | |||||||||
| 126891062 | 12689106 | 3 | SS | VINORELBINE | VINORELBINEVINORELBINE TARTRATE | 1 | Unknown | UNK, 3 CYCLES | U | U | 0 | ||||||||
| 126891062 | 12689106 | 4 | SS | Etanercept | ETANERCEPT | 1 | Unknown | UNK (A TOTAL OF 7 DOSES FROM DAYS +44 TO +69) | U | U | 0 | ||||||||
| 126891062 | 12689106 | 5 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 14.5 MG/KG, DAILY, FROM -6 TO -5 | U | U | 0 | 14.5 | MG/KG | ||||||
| 126891062 | 12689106 | 6 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 50 MG/KG,DAILY FROM FROM DAY +3 TO +4 | U | U | 0 | 50 | MG/KG | ||||||
| 126891062 | 12689106 | 7 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 30 MG/M2, DAILY, FROM DAY -6 TO -2 | U | U | 0 | 30 | MG/M**2 | ||||||
| 126891062 | 12689106 | 8 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | UNK | D | 0 | |||||||||
| 126891062 | 12689106 | 9 | SS | BICNU | CARMUSTINE | 1 | Unknown | UNK | D | 0 | |||||||||
| 126891062 | 12689106 | 10 | SS | Melphalan | MELPHALAN | 1 | Unknown | UNK | D | 0 | |||||||||
| 126891062 | 12689106 | 11 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | UNK, FROM DAY +5 | U | U | 0 | ||||||||
| 126891062 | 12689106 | 12 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | UNK, FROM +5 | U | U | 0 | ||||||||
| 126891062 | 12689106 | 13 | SS | GANCICLOVIR. | GANCICLOVIR | 1 | Unknown | UNK, FROM DAY +36 | U | U | 0 | ||||||||
| 126891062 | 12689106 | 14 | SS | Immunoglobulins | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK, TOTAL OF 7 DOSES FROM DAY +37 TO DAY +69 | U | U | 0 | ||||||||
| 126891062 | 12689106 | 15 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126891062 | 12689106 | 1 | Hodgkin's disease |
| 126891062 | 12689106 | 2 | Hodgkin's disease |
| 126891062 | 12689106 | 3 | Hodgkin's disease |
| 126891062 | 12689106 | 4 | Pneumonia |
| 126891062 | 12689106 | 5 | Hodgkin's disease |
| 126891062 | 12689106 | 7 | Hodgkin's disease |
| 126891062 | 12689106 | 8 | Hodgkin's disease |
| 126891062 | 12689106 | 9 | Hodgkin's disease |
| 126891062 | 12689106 | 10 | Hodgkin's disease |
| 126891062 | 12689106 | 11 | Hodgkin's disease |
| 126891062 | 12689106 | 12 | Hodgkin's disease |
| 126891062 | 12689106 | 13 | Cytomegalovirus infection |
| 126891062 | 12689106 | 14 | Cytomegalovirus infection |
| 126891062 | 12689106 | 15 | Pneumonia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126891062 | 12689106 | OT |
| 126891062 | 12689106 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126891062 | 12689106 | Complex partial seizures | |
| 126891062 | 12689106 | Cystitis haemorrhagic | |
| 126891062 | 12689106 | Cytomegalovirus infection | |
| 126891062 | 12689106 | Death | |
| 126891062 | 12689106 | Disease progression | |
| 126891062 | 12689106 | Disease recurrence | |
| 126891062 | 12689106 | Human polyomavirus infection | |
| 126891062 | 12689106 | Hypercalcaemia | |
| 126891062 | 12689106 | Hypertension | |
| 126891062 | 12689106 | Idiopathic pneumonia syndrome | |
| 126891062 | 12689106 | Pericardial effusion | |
| 126891062 | 12689106 | Pleural effusion | |
| 126891062 | 12689106 | Renal impairment | |
| 126891062 | 12689106 | Respiratory distress | |
| 126891062 | 12689106 | Thrombotic microangiopathy |
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 |
|---|---|---|---|---|---|---|
| 126891062 | 12689106 | 1 | 201407 | 201409 | 0 | |
| 126891062 | 12689106 | 3 | 201407 | 201409 | 0 |