NCT00025259 · ADVERSE EVENTS

Adverse events

Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease · Source last updated 2017-04-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Not reported
Other-event reporting threshold: 0%

Serious AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). Other AE: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (Patients Off-therapy Before Callback-Induction Only) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	1 / 38	23 / 38	Not reported / Not reported
Arm II (RER With CR [ABVE-PC, IFRT]) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	2 / 380	341 / 380	Not reported / Not reported
Arm III (RER With CR [ABVE-PC]) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	1 / 382	334 / 382	Not reported / Not reported
Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	5 / 571	497 / 571	Not reported / Not reported
Arm V (RER With PD) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	1 / 36	26 / 36	Not reported / Not reported
Arm VI (SER [DECA, ABVE-PC, IFRT]) Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, \& cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 \& 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 \& G-CSF SC beginning on day 3 \& continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cisplatin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Dexamethasone: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Pre	2 / 153	135 / 153	Not reported / Not reported
Arm VII (SER [ABVE-PC, IFRT]) Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV	1 / 152	133 / 152	Not reported / Not reported

Group identifiers: EG000: Arm I (Patients Off-therapy Before Callback-Induction Only) · EG001: Arm II (RER With CR [ABVE-PC, IFRT]) · EG002: Arm III (RER With CR [ABVE-PC]) · EG003: Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) · EG004: Arm V (RER With PD) · EG005: Arm VI (SER [DECA, ABVE-PC, IFRT]) · EG006: Arm VII (SER [ABVE-PC, IFRT])

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Anemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Blood and lymphatic system disorders - Other, specify
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
1
num At Risk
382
num Events
1
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Febrile neutropenia
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
1
num At Risk
152
num Events
1
term
Nausea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Vomiting
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
2
num At Risk
571
num Events
2
group Id
EG004
num Affected
1
num At Risk
36
num Events
1
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
1
num At Risk
152
num Events
1
term
Anaphylaxis
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
1
num At Risk
571
num Events
1
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Blood antidiuretic hormone abnormal
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
1
num At Risk
571
num Events
1
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Lymphocyte count decreased
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
2
num At Risk
380
num Events
2
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Neutrophil count decreased
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Platelet count decreased
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
2
num At Risk
571
num Events
2
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
White blood cell decreased

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
4
num At Risk
38
num Events
4
group Id
EG001
num Affected
196
num At Risk
380
num Events
196
group Id
EG002
num Affected
162
num At Risk
382
num Events
162
group Id
EG003
num Affected
245
num At Risk
571
num Events
245
group Id
EG004
num Affected
12
num At Risk
36
num Events
12
group Id
EG005
num Affected
85
num At Risk
153
num Events
85
group Id
EG006
num Affected
63
num At Risk
152
num Events
63
term
Anemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
38
num Events
1
group Id
EG001
num Affected
50
num At Risk
380
num Events
50
group Id
EG002
num Affected
35
num At Risk
382
num Events
35
group Id
EG003
num Affected
57
num At Risk
571
num Events
57
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
31
num At Risk
153
num Events
31
group Id
EG006
num Affected
20
num At Risk
152
num Events
20
term
Blood and lymphatic system disorders - Other, specify
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
38
num Events
1
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Disseminated intravascular coagulation
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
38
num Events
5
group Id
EG001
num Affected
111
num At Risk
380
num Events
111
group Id
EG002
num Affected
99
num At Risk
382
num Events
99
group Id
EG003
num Affected
128
num At Risk
571
num Events
128
group Id
EG004
num Affected
3
num At Risk
36
num Events
3
group Id
EG005
num Affected
45
num At Risk
153
num Events
45
group Id
EG006
num Affected
31
num At Risk
152
num Events
31
term
Febrile neutropenia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
38
num Events
2
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
2
num At Risk
382
num Events
2
group Id
EG003
num Affected
1
num At Risk
571
num Events
1
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
3
num At Risk
153
num Events
3
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Cardiac disorders - Other, specify
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
38
num Events
1
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Left ventricular systolic dysfunction
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
2
num At Risk
571
num Events
2
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Sinus tachycardia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Supraventricular tachycardia
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Hearing impaired
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
1
num At Risk
382
num Events
1
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Endocrine disorders - Other, specify
organ System
Eye disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
1
num At Risk
382
num Events
1
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Blurred vision
organ System
Eye disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Eye disorders - Other, specify

Complete source fields

description

event Groups

description
Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
id
EG000
other Num Affected
23
other Num At Risk
38
serious Num Affected
1
serious Num At Risk
38
title
Arm I (Patients Off-therapy Before Callback-Induction Only)
description
Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
id
EG001
other Num Affected
341
other Num At Risk
380
serious Num Affected
2
serious Num At Risk
380
title
Arm II (RER With CR [ABVE-PC, IFRT])
description
Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
id
EG002
other Num Affected
334
other Num At Risk
382
serious Num Affected
1
serious Num At Risk
382
title
Arm III (RER With CR [ABVE-PC])
description
Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
id
EG003
other Num Affected
497
other Num At Risk
571
serious Num Affected
5
serious Num At Risk
571
title
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
description
Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
id
EG004
other Num Affected
26
other Num At Risk
36
serious Num Affected
1
serious Num At Risk
36
title
Arm V (RER With PD)
description
Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, \& cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 \& 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 \& G-CSF SC beginning on day 3 \& continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cisplatin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Dexamethasone: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Pre
id
EG005
other Num Affected
135
other Num At Risk
153
serious Num Affected
2
serious Num At Risk
153
title
Arm VI (SER [DECA, ABVE-PC, IFRT])
description
Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
id
EG006
other Num Affected
133
other Num At Risk
152
serious Num Affected
1
serious Num At Risk
152
title
Arm VII (SER [ABVE-PC, IFRT])

frequency Threshold

other Events

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
4
num At Risk
38
num Events
4
group Id
EG001
num Affected
196
num At Risk
380
num Events
196
group Id
EG002
num Affected
162
num At Risk
382
num Events
162
group Id
EG003
num Affected
245
num At Risk
571
num Events
245
group Id
EG004
num Affected
12
num At Risk
36
num Events
12
group Id
EG005
num Affected
85
num At Risk
153
num Events
85
group Id
EG006
num Affected
63
num At Risk
152
num Events
63
term
Anemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
38
num Events
1
group Id
EG001
num Affected
50
num At Risk
380
num Events
50
group Id
EG002
num Affected
35
num At Risk
382
num Events
35
group Id
EG003
num Affected
57
num At Risk
571
num Events
57
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
31
num At Risk
153
num Events
31
group Id
EG006
num Affected
20
num At Risk
152
num Events
20
term
Blood and lymphatic system disorders - Other, specify
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
38
num Events
1
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Disseminated intravascular coagulation
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
38
num Events
5
group Id
EG001
num Affected
111
num At Risk
380
num Events
111
group Id
EG002
num Affected
99
num At Risk
382
num Events
99
group Id
EG003
num Affected
128
num At Risk
571
num Events
128
group Id
EG004
num Affected
3
num At Risk
36
num Events
3
group Id
EG005
num Affected
45
num At Risk
153
num Events
45
group Id
EG006
num Affected
31
num At Risk
152
num Events
31
term
Febrile neutropenia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
38
num Events
2
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
2
num At Risk
382
num Events
2
group Id
EG003
num Affected
1
num At Risk
571
num Events
1
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
3
num At Risk
153
num Events
3
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Cardiac disorders - Other, specify
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
38
num Events
1
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Left ventricular systolic dysfunction
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
2
num At Risk
571
num Events
2
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Sinus tachycardia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Supraventricular tachycardia
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Hearing impaired
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
1
num At Risk
382
num Events
1
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Endocrine disorders - Other, specify
organ System
Eye disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
1
num At Risk
382
num Events
1
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Blurred vision
organ System
Eye disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Eye disorders - Other, specify

serious Events

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Anemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Blood and lymphatic system disorders - Other, specify
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
1
num At Risk
382
num Events
1
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Febrile neutropenia
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
1
num At Risk
152
num Events
1
term
Nausea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Vomiting
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
2
num At Risk
571
num Events
2
group Id
EG004
num Affected
1
num At Risk
36
num Events
1
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
1
num At Risk
152
num Events
1
term
Anaphylaxis
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
0
num At Risk
380
num Events
0
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
1
num At Risk
571
num Events
1
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Blood antidiuretic hormone abnormal
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
1
num At Risk
571
num Events
1
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
0
num At Risk
153
num Events
0
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Lymphocyte count decreased
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
2
num At Risk
380
num Events
2
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Neutrophil count decreased
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
0
num At Risk
571
num Events
0
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
Platelet count decreased
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
38
num Events
0
group Id
EG001
num Affected
1
num At Risk
380
num Events
1
group Id
EG002
num Affected
0
num At Risk
382
num Events
0
group Id
EG003
num Affected
2
num At Risk
571
num Events
2
group Id
EG004
num Affected
0
num At Risk
36
num Events
0
group Id
EG005
num Affected
1
num At Risk
153
num Events
1
group Id
EG006
num Affected
0
num At Risk
152
num Events
0
term
White blood cell decreased

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice