NCT01076543 · ADVERSE EVENTS

Adverse events

Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma · Source last updated 2019-10-16

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: Mortality collected up to 6 years; all other AEs collected up to 2 years.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I, All Histologies, Lenalidomide 15 mg Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	2 / 8	8 / 8	4 / 8
Phase I, All Histologies, Lenalidomide 20 mg Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	2 / 3	3 / 3	3 / 3
Phase I, All Histologies, Lenalidomide 25 mg Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	5 / 6	6 / 6	4 / 6
Phase II, Diffuse Large B-Cell Subtype Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	22 / 39	39 / 39	23 / 39
Phase II, Follicular Subtype Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	7 / 15	13 / 15	4 / 15
Phase II, Lymphoma NOS Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .	22 / 39	39 / 39	18 / 39

Group identifiers: EG000: Phase I, All Histologies, Lenalidomide 15 mg · EG001: Phase I, All Histologies, Lenalidomide 20 mg · EG002: Phase I, All Histologies, Lenalidomide 25 mg · EG003: Phase II, Diffuse Large B-Cell Subtype · EG004: Phase II, Follicular Subtype · EG005: Phase II, Lymphoma NOS

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
1
num At Risk
15
group Id
EG005
num Affected
1
num At Risk
39
term
Pneumonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
2
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
1
num At Risk
39
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Hypophosphatemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
2
num At Risk
39
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Chest pain - cardiac
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Hyperglycemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Hyponatremia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
1
num At Risk
39
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
1
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Lymphocyte count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Oral pain

Other reported adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
9
num At Risk
39
group Id
EG004
num Affected
1
num At Risk
15
group Id
EG005
num Affected
7
num At Risk
39
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
6
group Id
EG003
num Affected
12
num At Risk
39
group Id
EG004
num Affected
7
num At Risk
15
group Id
EG005
num Affected
21
num At Risk
39
term
Alkaline aminotransferase increase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
9
num At Risk
39
group Id
EG004
num Affected
6
num At Risk
15
group Id
EG005
num Affected
17
num At Risk
39
term
Alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
3
num At Risk
39
group Id
EG004
num Affected
2
num At Risk
15
group Id
EG005
num Affected
5
num At Risk
39
term
Allergic rhinitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
7
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
4
num At Risk
6
group Id
EG003
num Affected
33
num At Risk
39
group Id
EG004
num Affected
10
num At Risk
15
group Id
EG005
num Affected
36
num At Risk
39
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
3
num At Risk
6
group Id
EG003
num Affected
20
num At Risk
39
group Id
EG004
num Affected
8
num At Risk
15
group Id
EG005
num Affected
18
num At Risk
39
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
15
num At Risk
39
group Id
EG004
num Affected
6
num At Risk
15
group Id
EG005
num Affected
20
num At Risk
39
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
7
num At Risk
39
group Id
EG004
num Affected
2
num At Risk
15
group Id
EG005
num Affected
9
num At Risk
39
term
Bleeding
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
1
num At Risk
15
group Id
EG005
num Affected
2
num At Risk
39
term
Blood bilirubin increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
5
num At Risk
39
group Id
EG004
num Affected
2
num At Risk
15
group Id
EG005
num Affected
9
num At Risk
39
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
11
num At Risk
39
group Id
EG004
num Affected
3
num At Risk
15
group Id
EG005
num Affected
16
num At Risk
39
term
Cholesterol high
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
6
group Id
EG003
num Affected
17
num At Risk
39
group Id
EG004
num Affected
8
num At Risk
15
group Id
EG005
num Affected
18
num At Risk
39
term
Constipation

Complete source fields

event Groups

deaths Num Affected
4
deaths Num At Risk
8
description
Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
id
EG000
other Num Affected
8
other Num At Risk
8
serious Num Affected
2
serious Num At Risk
8
title
Phase I, All Histologies, Lenalidomide 15 mg
deaths Num Affected
3
deaths Num At Risk
3
description
Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Phase I, All Histologies, Lenalidomide 20 mg
deaths Num Affected
4
deaths Num At Risk
6
description
Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
id
EG002
other Num Affected
6
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
Phase I, All Histologies, Lenalidomide 25 mg
deaths Num Affected
23
deaths Num At Risk
39
description
Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
id
EG003
other Num Affected
39
other Num At Risk
39
serious Num Affected
22
serious Num At Risk
39
title
Phase II, Diffuse Large B-Cell Subtype
deaths Num Affected
4
deaths Num At Risk
15
description
Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
id
EG004
other Num Affected
13
other Num At Risk
15
serious Num Affected
7
serious Num At Risk
15
title
Phase II, Follicular Subtype
deaths Num Affected
18
deaths Num At Risk
39
description
Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
id
EG005
other Num Affected
39
other Num At Risk
39
serious Num Affected
22
serious Num At Risk
39
title
Phase II, Lymphoma NOS

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
9
num At Risk
39
group Id
EG004
num Affected
1
num At Risk
15
group Id
EG005
num Affected
7
num At Risk
39
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
6
group Id
EG003
num Affected
12
num At Risk
39
group Id
EG004
num Affected
7
num At Risk
15
group Id
EG005
num Affected
21
num At Risk
39
term
Alkaline aminotransferase increase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
9
num At Risk
39
group Id
EG004
num Affected
6
num At Risk
15
group Id
EG005
num Affected
17
num At Risk
39
term
Alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
3
num At Risk
39
group Id
EG004
num Affected
2
num At Risk
15
group Id
EG005
num Affected
5
num At Risk
39
term
Allergic rhinitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
7
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
4
num At Risk
6
group Id
EG003
num Affected
33
num At Risk
39
group Id
EG004
num Affected
10
num At Risk
15
group Id
EG005
num Affected
36
num At Risk
39
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
3
num At Risk
6
group Id
EG003
num Affected
20
num At Risk
39
group Id
EG004
num Affected
8
num At Risk
15
group Id
EG005
num Affected
18
num At Risk
39
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
15
num At Risk
39
group Id
EG004
num Affected
6
num At Risk
15
group Id
EG005
num Affected
20
num At Risk
39
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
7
num At Risk
39
group Id
EG004
num Affected
2
num At Risk
15
group Id
EG005
num Affected
9
num At Risk
39
term
Bleeding
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
1
num At Risk
15
group Id
EG005
num Affected
2
num At Risk
39
term
Blood bilirubin increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
5
num At Risk
39
group Id
EG004
num Affected
2
num At Risk
15
group Id
EG005
num Affected
9
num At Risk
39
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
11
num At Risk
39
group Id
EG004
num Affected
3
num At Risk
15
group Id
EG005
num Affected
16
num At Risk
39
term
Cholesterol high
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
6
group Id
EG003
num Affected
17
num At Risk
39
group Id
EG004
num Affected
8
num At Risk
15
group Id
EG005
num Affected
18
num At Risk
39
term
Constipation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
1
num At Risk
15
group Id
EG005
num Affected
1
num At Risk
39
term
Pneumonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
2
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
1
num At Risk
39
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Hypophosphatemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
2
num At Risk
39
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Chest pain - cardiac
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Hyperglycemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Hyponatremia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
1
num At Risk
39
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
1
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Lymphocyte count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
39
group Id
EG004
num Affected
0
num At Risk
15
group Id
EG005
num Affected
0
num At Risk
39
term
Oral pain

time Frame

Mortality collected up to 6 years; all other AEs collected up to 2 years.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice