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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118640653 | 11864065 | 3 | F | 20151007 | 20160923 | 20151223 | 20160928 | EXP | US-009507513-1512USA010972 | MERCK | 18.00 | YR | M | Y | 109.00000 | KG | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118640653 | 11864065 | 1 | PS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | PRO-PHASE, 5 MG/M2, ONCE DAILY ON DAYS 1-2 (CYCLE=5 DAYS)AND 5 MG/M2 TWICE DAILY ON DAYS 3-5 | 12675 | 5 | MG/M**2 | TABLET | |||||||
| 118640653 | 11864065 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 5 MG/M2, TWICE A DAY ON DAYS 1-5 (CYCLE=21 DAYS) | 12675 | 5 | MG/M**2 | TABLET | |||||||
| 118640653 | 11864065 | 3 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 25MG/M2, IV OVER 1-15 MIN ON DAYS 4 AND 5 (CYCLE 2, CYCLE=21 DAYS) | 0 | 25 | MG/M**2 | INJECTION | |||||||
| 118640653 | 11864065 | 4 | SS | CRIZOTINIB | CRIZOTINIB | 1 | Oral | 165 MG/M2 (ALSO REPORTED AS 250 MG) TWICE A DAY ON DAYS 1-21 (CYCLE=21 DAYS) | Y | 0 | 165 | MG/M**2 | |||||||
| 118640653 | 11864065 | 5 | SS | CRIZOTINIB | CRIZOTINIB | 1 | Oral | AT UNSPECIFIED REDUCED DOSE, CYCLICAL | Y | 0 | |||||||||
| 118640653 | 11864065 | 6 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 200 MG/M2 IV OVER 15-30 MINUTES ON DAYS 1-2 (PRO-PHASE, CYCLE=5 DAYS) | 0 | 200 | MG/M**2 | ||||||||
| 118640653 | 11864065 | 7 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 200 MG/M2 IV OVER 15-30 MINUTES ON DAYS 1-5 (CYCLE 2, CYCLE=21 DAYS) | 0 | 200 | MG/M**2 | ||||||||
| 118640653 | 11864065 | 8 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Intrathecal | 7.5-12 MG ON DAY 1(AGE BASED DOSING) (PRO-PHASE, CYCLE=5 DAYS) | 0 | ||||||||||
| 118640653 | 11864065 | 9 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Intrathecal | 3000 MG/M2 IV OVER 3 HOURS ON DAY 1 (CYCLE=21 DAYS) | 0 | ||||||||||
| 118640653 | 11864065 | 10 | SS | CYTARABINE. | CYTARABINE | 1 | Intrathecal | 15-24 MG ON DAY 1(AGE BASED DOSING) (PRO-PHASE, CYCLE=5 DAYS) | 0 | SOLUTION FOR INJECTION | |||||||||
| 118640653 | 11864065 | 11 | SS | CYTARABINE. | CYTARABINE | 1 | Intrathecal | 150 MG/M2 IV OVER 1-30 MINUTES EVERY 12 HOURS ON DAYS 4 AND 5 (TOTAL 4 DOSES) (CYCLE 1, CYCLE= 21 DA | 0 | 150 | MG/M**2 | SOLUTION FOR INJECTION | |||||||
| 118640653 | 11864065 | 12 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 800 MG/M2 IV OVER 60 MIN ON DAYS 1-5 (CYCLE1, CYCLE=21 DAYS) | 0 | 800 | MG/M**2 | ||||||||
| 118640653 | 11864065 | 13 | SS | HYDROCORTISONE ACETATE. | HYDROCORTISONE ACETATE | 1 | Intrathecal | 7.5-12 MG ON DAY 1 (AGE BASED DOSING) (PRO-PHASE, CYCE=5 DAYS) | D | 0 | |||||||||
| 118640653 | 11864065 | 14 | SS | VP-16 | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 100 MG/M2 IV OVER 2 HOURS ON DAYS 4-5 (CYCLE 1, CYCLE=21 DAYS) | D | 0 | 100 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118640653 | 11864065 | 1 | Anaplastic large cell lymphoma T- and null-cell types |
| 118640653 | 11864065 | 3 | Anaplastic large cell lymphoma T- and null-cell types |
| 118640653 | 11864065 | 4 | Anaplastic large cell lymphoma T- and null-cell types |
| 118640653 | 11864065 | 6 | Anaplastic large cell lymphoma T- and null-cell types |
| 118640653 | 11864065 | 8 | Anaplastic large cell lymphoma T- and null-cell types |
| 118640653 | 11864065 | 10 | Anaplastic large cell lymphoma T- and null-cell types |
| 118640653 | 11864065 | 12 | Anaplastic large cell lymphoma T- and null-cell types |
| 118640653 | 11864065 | 13 | Anaplastic large cell lymphoma T- and null-cell types |
| 118640653 | 11864065 | 14 | Anaplastic large cell lymphoma T- and null-cell types |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118640653 | 11864065 | HO |
| 118640653 | 11864065 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118640653 | 11864065 | Enterocolitis | |
| 118640653 | 11864065 | Hypokalaemia | |
| 118640653 | 11864065 | Lung infection | |
| 118640653 | 11864065 | Nausea | |
| 118640653 | 11864065 | Pleural effusion | |
| 118640653 | 11864065 | Stomatitis | |
| 118640653 | 11864065 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 118640653 | 11864065 | 1 | 20150903 | 0 | ||
| 118640653 | 11864065 | 2 | 20150908 | 0 | ||
| 118640653 | 11864065 | 3 | 20151002 | 20151003 | 0 | |
| 118640653 | 11864065 | 4 | 20150908 | 20151013 | 0 | |
| 118640653 | 11864065 | 5 | 2015 | 0 | ||
| 118640653 | 11864065 | 6 | 20150903 | 0 | ||
| 118640653 | 11864065 | 7 | 20150929 | 20151003 | 0 | |
| 118640653 | 11864065 | 8 | 20150903 | 20150903 | 0 | |
| 118640653 | 11864065 | 9 | 20150929 | 0 | ||
| 118640653 | 11864065 | 10 | 20150903 | 20150903 | 0 | |
| 118640653 | 11864065 | 11 | 20150911 | 20150913 | 0 | |
| 118640653 | 11864065 | 12 | 20150908 | 20150912 | 0 | |
| 118640653 | 11864065 | 13 | 20150903 | 20150903 | 0 | |
| 118640653 | 11864065 | 14 | 20150911 | 20150912 | 0 |