NCT01026220 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma · Source last updated 2022-04-28

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%

Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Group 1 All Patients	0 / 165	89 / 165	Not reported / Not reported
Group 2 Regimen I	0 / 81	43 / 81	Not reported / Not reported
Group 3 Regimen II	0 / 80	46 / 80	Not reported / Not reported

Group identifiers: EG000: Group 1 · EG001: Group 2 · EG002: Group 3

Serious adverse events

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

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
1
num At Risk
165
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
1
num At Risk
80
num Events
1
term
Disseminated intravascular coagulation
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
39
num At Risk
165
num Events
39
group Id
EG001
num Affected
17
num At Risk
81
num Events
17
group Id
EG002
num Affected
22
num At Risk
80
num Events
22
term
Febrile neutropenia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
165
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
1
num At Risk
80
num Events
1
term
Cardiac disorders - Other, specify
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
1
num At Risk
165
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
1
num At Risk
80
num Events
1
term
Ear pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
165
num Events
4
group Id
EG001
num Affected
2
num At Risk
81
num Events
2
group Id
EG002
num Affected
2
num At Risk
80
num Events
2
term
Abdominal pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
165
num Events
1
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
0
num At Risk
80
num Events
0
term
Colitis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
165
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
1
num At Risk
80
num Events
1
term
Dysphagia
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
165
num Events
2
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
1
num At Risk
80
num Events
1
term
Esophageal pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
165
num Events
2
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
2
num At Risk
80
num Events
2
term
Esophagitis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
165
num Events
2
group Id
EG001
num Affected
2
num At Risk
81
num Events
2
group Id
EG002
num Affected
0
num At Risk
80
num Events
0
term
Gastritis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
21
num At Risk
165
num Events
21
group Id
EG001
num Affected
12
num At Risk
81
num Events
12
group Id
EG002
num Affected
9
num At Risk
80
num Events
9
term
Mucositis oral
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
165
num Events
5
group Id
EG001
num Affected
2
num At Risk
81
num Events
2
group Id
EG002
num Affected
3
num At Risk
80
num Events
3
term
Nausea

Complete source fields

description

event Groups

description
All Patients
id
EG000
other Num Affected
89
other Num At Risk
165
serious Num Affected
0
serious Num At Risk
165
title
Group 1
description
Regimen I
id
EG001
other Num Affected
43
other Num At Risk
81
serious Num Affected
0
serious Num At Risk
81
title
Group 2
description
Regimen II
id
EG002
other Num Affected
46
other Num At Risk
80
serious Num Affected
0
serious Num At Risk
80
title
Group 3

frequency Threshold

other Events

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
165
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
1
num At Risk
80
num Events
1
term
Disseminated intravascular coagulation
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
39
num At Risk
165
num Events
39
group Id
EG001
num Affected
17
num At Risk
81
num Events
17
group Id
EG002
num Affected
22
num At Risk
80
num Events
22
term
Febrile neutropenia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
165
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
1
num At Risk
80
num Events
1
term
Cardiac disorders - Other, specify
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
1
num At Risk
165
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
1
num At Risk
80
num Events
1
term
Ear pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
165
num Events
4
group Id
EG001
num Affected
2
num At Risk
81
num Events
2
group Id
EG002
num Affected
2
num At Risk
80
num Events
2
term
Abdominal pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
165
num Events
1
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
0
num At Risk
80
num Events
0
term
Colitis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
165
num Events
1
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
1
num At Risk
80
num Events
1
term
Dysphagia
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
165
num Events
2
group Id
EG001
num Affected
1
num At Risk
81
num Events
1
group Id
EG002
num Affected
1
num At Risk
80
num Events
1
term
Esophageal pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
165
num Events
2
group Id
EG001
num Affected
0
num At Risk
81
num Events
0
group Id
EG002
num Affected
2
num At Risk
80
num Events
2
term
Esophagitis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
165
num Events
2
group Id
EG001
num Affected
2
num At Risk
81
num Events
2
group Id
EG002
num Affected
0
num At Risk
80
num Events
0
term
Gastritis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
21
num At Risk
165
num Events
21
group Id
EG001
num Affected
12
num At Risk
81
num Events
12
group Id
EG002
num Affected
9
num At Risk
80
num Events
9
term
Mucositis oral
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
165
num Events
5
group Id
EG001
num Affected
2
num At Risk
81
num Events
2
group Id
EG002
num Affected
3
num At Risk
80
num Events
3
term
Nausea

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Preserved source evidence · Not medical advice