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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116562754 | 11656275 | 4 | F | 20150413 | 20160902 | 20151023 | 20160906 | EXP | US-009507513-1510USA009661 | MERCK | 8.00 | YR | M | Y | 27.00000 | KG | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116562754 | 11656275 | 1 | PS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 5 MG/M2, QD ON DAYS 1-2 AND THEN BID ON DAYS 3-5 OF PROPHASE | U | 12675 | 5 | MG/M**2 | TABLET | ||||||
| 116562754 | 11656275 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 5 MG/M2, BID ON DAYS 1-5 OF COURSE A | U | 12675 | 5 | MG/M**2 | TABLET | ||||||
| 116562754 | 11656275 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | UNK, CYCLICAL | U | 0 | TABLET | ||||||||
| 116562754 | 11656275 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | UNK UNK, CYCLICAL | U | 0 | TABLET | ||||||||
| 116562754 | 11656275 | 5 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intrathecal | UNK UNK, CYCLICAL | U | 0 | INJECTION | ||||||||
| 116562754 | 11656275 | 6 | SS | CRIZOTINIB | CRIZOTINIB | 1 | Oral | 165 MG/M2, BID ON DAYS 1-21 | 5610 | MG/M2 | 0 | 165 | MG/M**2 | CAPSULE | BID | ||||
| 116562754 | 11656275 | 7 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 800 MG/M2, OVER 60 MIN ON DAYS 1-5 | U | 0 | 800 | MG/M**2 | |||||||
| 116562754 | 11656275 | 8 | SS | CYTARABINE. | CYTARABINE | 1 | Intrathecal | 15-24 MG IT ON DAY 1 (AGE BASED DOSING) | U | 0 | |||||||||
| 116562754 | 11656275 | 9 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 150 MG/M2, OVER 1-30 MINUTES Q12H ON DAYS 4 AND 5(TOTAL 4 DOSES) | U | 0 | 150 | MG/M**2 | |||||||
| 116562754 | 11656275 | 10 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 100 MG/M2, OVER 2 HOURS ON DAYS 4 AND 5 | U | 0 | 100 | MG/M**2 | |||||||
| 116562754 | 11656275 | 11 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 200MG/M2 OVER 15-30 MINUTES ON DAYS 1AND2 | U | 0 | 200 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116562754 | 11656275 | 1 | Anaplastic large cell lymphoma T- and null-cell types |
| 116562754 | 11656275 | 3 | Anaplastic large cell lymphoma T- and null-cell types |
| 116562754 | 11656275 | 5 | Anaplastic large cell lymphoma T- and null-cell types |
| 116562754 | 11656275 | 6 | Anaplastic large cell lymphoma T- and null-cell types |
| 116562754 | 11656275 | 7 | Anaplastic large-cell lymphoma |
| 116562754 | 11656275 | 8 | Anaplastic large cell lymphoma T- and null-cell types |
| 116562754 | 11656275 | 10 | Anaplastic large cell lymphoma T- and null-cell types |
| 116562754 | 11656275 | 11 | Anaplastic large cell lymphoma T- and null-cell types |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116562754 | 11656275 | OT |
| 116562754 | 11656275 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116562754 | 11656275 | Febrile neutropenia | |
| 116562754 | 11656275 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 116562754 | 11656275 | 1 | 20150323 | 0 | ||
| 116562754 | 11656275 | 2 | 20150328 | 20150401 | 0 | |
| 116562754 | 11656275 | 3 | 20150323 | 0 | ||
| 116562754 | 11656275 | 4 | 20150328 | 0 | ||
| 116562754 | 11656275 | 5 | 20150323 | 20150328 | 0 | |
| 116562754 | 11656275 | 6 | 20150328 | 20150413 | 0 | |
| 116562754 | 11656275 | 7 | 20150328 | 20150401 | 0 | |
| 116562754 | 11656275 | 8 | 20150323 | 0 | ||
| 116562754 | 11656275 | 9 | 20150328 | 20150401 | 0 | |
| 116562754 | 11656275 | 10 | 2015 | 20150401 | 0 | |
| 116562754 | 11656275 | 11 | 20150323 | 0 |