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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115843535 | 11584353 | 5 | F | 20140719 | 20160916 | 20151001 | 20160921 | EXP | US-009507513-1509USA014548 | MERCK | 17.00 | YR | M | Y | 61.08000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115843535 | 11584353 | 1 | PS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 9 MG, PROPHASE, DAILY ON DAYS 1-2 AND TWICE DAILY ON DAYS 3-5 | 516 | MG | 12675 | 9 | MG | TABLET | QD | ||||
| 115843535 | 11584353 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 9 MG, COURSE A AND B, TWICE DAILY ON DAYS 1-5 | 516 | MG | 12675 | 9 | MG | TABLET | BID | ||||
| 115843535 | 11584353 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 8.75 MG COURSE A AND B, TWICE DAILY ON DAYS 1-5 | 516 | MG | 12675 | 8.75 | MG | TABLET | BID | ||||
| 115843535 | 11584353 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 8.75 MG COURSE A AND B, TWICE DAILY ON DAYS 1-5 | 516 | MG | 12675 | 8.75 | MG | TABLET | BID | ||||
| 115843535 | 11584353 | 5 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 9 MG, COURSE A AND B, TWICE DAILY ON DAYS 1-5 | 516 | MG | 12675 | 9 | MG | TABLET | BID | ||||
| 115843535 | 11584353 | 6 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 8.75 MG COURSE A AND B, TWICE DAILY ON DAYS 1-5 | 516 | MG | 12675 | 8.75 | MG | TABLET | BID | ||||
| 115843535 | 11584353 | 7 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | UNK | 516 | MG | 12675 | TABLET | ||||||||
| 115843535 | 11584353 | 8 | SS | EMEND | APREPITANT | 1 | U | 0 | CAPSULE | ||||||||||
| 115843535 | 11584353 | 9 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intratracheal | 12 MG, CYCLICAL | 0 | 12 | MG | TABLET | |||||||
| 115843535 | 11584353 | 10 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 5460 MG, COURSE A AND B, OVER 3 HOURS ON DAY 1 | 0 | TABLET | |||||||||
| 115843535 | 11584353 | 11 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 5220 MG, COURSE A AND B, OVER 3 HOURS ON DAY 1 | 0 | TABLET | |||||||||
| 115843535 | 11584353 | 12 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 5220 MG, COURSE A AND B, OVER 3 HOURS ON DAY 1 | 0 | TABLET | |||||||||
| 115843535 | 11584353 | 13 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 5280 MG, COURSE A AND B, OVER 3 HOURS ON DAY 1 | 0 | TABLET | |||||||||
| 115843535 | 11584353 | 14 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 5160 MG, COURSE A AND B, OVER 3 HOURS ON DAY 1 | 0 | TABLET | |||||||||
| 115843535 | 11584353 | 15 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intratracheal | 12 MG, ONCE | 12 | MG | D | 0 | 12 | MG | INJECTION | 1X | |||
| 115843535 | 11584353 | 16 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intrathecal | 7.5-12 MG ON DAY 1, PROPHASE | 12 | MG | D | 0 | INJECTION | 1X | |||||
| 115843535 | 11584353 | 17 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 44 MG, COURSE B, OVER 1-15 MIN ON DAYS 4 AND 5 | 0 | 44 | MG | INJECTION | |||||||
| 115843535 | 11584353 | 18 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 44 MG, COURSE B, OVER 1-15 MIN ON DAYS 4 AND 5 | 0 | 44 | MG | INJECTION | |||||||
| 115843535 | 11584353 | 19 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 1 IN 1 CYCLICAL | 0 | INJECTION | |||||||||
| 115843535 | 11584353 | 20 | SS | CRIZOTINIB | CRIZOTINIB | 1 | Oral | 165 MG/M2, BID (CYCLIC), ON DAYS 1-21 EVERY 21 DAYS CYCLE | 0 | 165 | MG/M**2 | ||||||||
| 115843535 | 11584353 | 21 | SS | CRIZOTINIB | CRIZOTINIB | 1 | Oral | 165 MG/M2, BID (CYCLIC), ON DAYS 1-21 EVERY 21 DAYS CYCLE | 0 | 165 | MG/M**2 | ||||||||
| 115843535 | 11584353 | 22 | SS | CRIZOTINIB | CRIZOTINIB | 1 | Oral | 165 MG/M2, BID (CYCLIC), ON DAYS 1-21 EVERY 21 DAYS CYCLE | 0 | 165 | MG/M**2 | ||||||||
| 115843535 | 11584353 | 23 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 362 MG, PROPHASE, OVER 15-30 MINUTES ON DAYS 1 AND 2 | 0 | 362 | MG | ||||||||
| 115843535 | 11584353 | 24 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 348 MG, PROPHASE, OVER 15-30 MINUTES ON DAYS 1 AND 2 | 0 | 348 | MG | ||||||||
| 115843535 | 11584353 | 25 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 352 MG, PROPHASE, OVER 15-30 MINUTES ON DAYS 1-5 (348 MG, 5 IN 21 D) DAYS | 0 | 352 | MG | ||||||||
| 115843535 | 11584353 | 26 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 1 IN 1 CYCLICAL | 0 | ||||||||||
| 115843535 | 11584353 | 27 | SS | CYTARABINE. | CYTARABINE | 1 | Intratracheal | 24 MG, ONCE | 3746 | MG | 0 | 24 | MG | 1X | |||||
| 115843535 | 11584353 | 28 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 273 MG, Q12H | 3746 | MG | 0 | 273 | MG | Q12H | |||||
| 115843535 | 11584353 | 29 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 261 MG, Q12H | 3746 | MG | 0 | 261 | MG | Q12H | |||||
| 115843535 | 11584353 | 30 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 260 MG, Q12H | 3746 | MG | 0 | 260 | MG | Q12H | |||||
| 115843535 | 11584353 | 31 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 1456 MG DAILY | 0 | QD | |||||||||
| 115843535 | 11584353 | 32 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 1392 MG DAILY | 0 | QD | |||||||||
| 115843535 | 11584353 | 33 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 1376 MG DAILY | 0 | QD | |||||||||
| 115843535 | 11584353 | 34 | SS | VP-16 | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 182 MG, UNK | 0 | 182 | MG | ||||||||
| 115843535 | 11584353 | 35 | SS | VP-16 | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 179 MG, UNK | 0 | 179 | MG | ||||||||
| 115843535 | 11584353 | 36 | SS | VP-16 | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 172 MG, UNK | 0 | 172 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115843535 | 11584353 | 1 | Anaplastic large cell lymphoma T- and null-cell types |
| 115843535 | 11584353 | 9 | Anaplastic large cell lymphoma T- and null-cell types |
| 115843535 | 11584353 | 15 | Anaplastic large cell lymphoma T- and null-cell types |
| 115843535 | 11584353 | 17 | Anaplastic large cell lymphoma T- and null-cell types |
| 115843535 | 11584353 | 20 | Anaplastic large cell lymphoma T- and null-cell types |
| 115843535 | 11584353 | 23 | Anaplastic large cell lymphoma T- and null-cell types |
| 115843535 | 11584353 | 27 | Anaplastic large cell lymphoma T- and null-cell types |
| 115843535 | 11584353 | 31 | Anaplastic large cell lymphoma T- and null-cell types |
| 115843535 | 11584353 | 34 | Anaplastic large cell lymphoma T- and null-cell types |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115843535 | 11584353 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115843535 | 11584353 | Hyponatraemia | |
| 115843535 | 11584353 | Oesophagitis | |
| 115843535 | 11584353 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 115843535 | 11584353 | 1 | 20140703 | 0 | ||
| 115843535 | 11584353 | 2 | 20140710 | 20140717 | 0 | |
| 115843535 | 11584353 | 3 | 20140804 | 20140808 | 0 | |
| 115843535 | 11584353 | 4 | 20140830 | 20140903 | 0 | |
| 115843535 | 11584353 | 5 | 20140919 | 20140923 | 0 | |
| 115843535 | 11584353 | 6 | 20141013 | 20141017 | 0 | |
| 115843535 | 11584353 | 9 | 20140703 | 20140703 | 0 | |
| 115843535 | 11584353 | 10 | 20140713 | 0 | ||
| 115843535 | 11584353 | 11 | 20140805 | 0 | ||
| 115843535 | 11584353 | 12 | 20140830 | 0 | ||
| 115843535 | 11584353 | 13 | 20140919 | 0 | ||
| 115843535 | 11584353 | 14 | 20141013 | 0 | ||
| 115843535 | 11584353 | 15 | 20140703 | 20140703 | 0 | |
| 115843535 | 11584353 | 16 | 20140708 | 20140708 | 0 | |
| 115843535 | 11584353 | 17 | 20140808 | 20140809 | 0 | |
| 115843535 | 11584353 | 18 | 20140922 | 20140923 | 0 | |
| 115843535 | 11584353 | 19 | 20141106 | 20141107 | 0 | |
| 115843535 | 11584353 | 20 | 20140708 | 20140816 | 0 | |
| 115843535 | 11584353 | 21 | 20141103 | 20141120 | 0 | |
| 115843535 | 11584353 | 23 | 20140703 | 0 | ||
| 115843535 | 11584353 | 24 | 20140805 | 20140809 | 0 | |
| 115843535 | 11584353 | 25 | 20140919 | 20140923 | 0 | |
| 115843535 | 11584353 | 26 | 20141103 | 20141107 | 0 | |
| 115843535 | 11584353 | 27 | 20140703 | 20140703 | 0 | |
| 115843535 | 11584353 | 28 | 20140716 | 20140718 | 0 | |
| 115843535 | 11584353 | 29 | 20140902 | 20140903 | 0 | |
| 115843535 | 11584353 | 30 | 20141016 | 20141017 | 0 | |
| 115843535 | 11584353 | 31 | 20140713 | 20140717 | 0 | |
| 115843535 | 11584353 | 32 | 20140830 | 20140903 | 0 | |
| 115843535 | 11584353 | 33 | 20141013 | 20141017 | 0 | |
| 115843535 | 11584353 | 34 | 20140716 | 20140717 | 0 | |
| 115843535 | 11584353 | 35 | 20140902 | 20140903 | 0 | |
| 115843535 | 11584353 | 36 | 20141016 | 20141017 | 0 |