NCT02213913 · ADVERSE EVENTS

Adverse events

Lenalidomide and Combination Chemotherapy (DA-EPOCH-R) in Treating Patients With MYC-Associated B-Cell Lymphomas · Source last updated 2026-03-11

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: Up to 5 years.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Lenalidomide 10 mg , DA-EPOCH-R) INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV	2 / 3	3 / 3	1 / 3
Treatment (Lenalidomide 15 mg, DA-EPOCH-R) Phase I Cohort 2: INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV	2 / 7	7 / 7	2 / 7
Treatment (Lenalidomide 20 mg, DA-EPOCH-R) Phase I Cohort 3: INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV	5 / 5	5 / 5	0 / 5
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R) Phase II Cohort 4: INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV	21 / 40	39 / 40	10 / 40

Group identifiers: EG000: Treatment (Lenalidomide 10 mg , DA-EPOCH-R) · EG001: Treatment (Lenalidomide 15 mg, DA-EPOCH-R) · EG002: Treatment (Lenalidomide 20 mg, DA-EPOCH-R) · EG003: Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)

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
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
40
term
Anorexia
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
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
40
term
Aspiration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
40
term
Chest pain - cardiac
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
40
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
40
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
40
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
40
term
Fatigue
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
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
13
num At Risk
40
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
40
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
40
term
Flu like symptoms
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
40
term
Hip fracture
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
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
40
term
Hyponatremia

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
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
11
num At Risk
40
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
40
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
8
num At Risk
40
term
Alanine aminotransferase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
3
num At Risk
40
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
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
8
num At Risk
40
term
Allergic rhinitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
4
num At Risk
5
group Id
EG003
num Affected
13
num At Risk
40
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
5
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
5
group Id
EG003
num Affected
32
num At Risk
40
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
14
num At Risk
40
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
4
num At Risk
40
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
7
num At Risk
40
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
5
num At Risk
40
term
Aspartate aminotransferase increase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
8
num At Risk
40
term
Back pain

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
3
description
INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Treatment (Lenalidomide 10 mg , DA-EPOCH-R)
deaths Num Affected
2
deaths Num At Risk
7
description
Phase I Cohort 2: INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV
id
EG001
other Num Affected
7
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
deaths Num Affected
0
deaths Num At Risk
5
description
Phase I Cohort 3: INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV
id
EG002
other Num Affected
5
other Num At Risk
5
serious Num Affected
5
serious Num At Risk
5
title
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
deaths Num Affected
10
deaths Num At Risk
40
description
Phase II Cohort 4: INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months. lenalidomide: Given PO etoposide: Given IV prednisone: Given PO vincristine sulfate: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV rituximab: Given IV
id
EG003
other Num Affected
39
other Num At Risk
40
serious Num Affected
21
serious Num At Risk
40
title
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
11
num At Risk
40
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
40
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
8
num At Risk
40
term
Alanine aminotransferase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
3
num At Risk
40
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
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
8
num At Risk
40
term
Allergic rhinitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
4
num At Risk
5
group Id
EG003
num Affected
13
num At Risk
40
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
5
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
5
group Id
EG003
num Affected
32
num At Risk
40
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
14
num At Risk
40
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
4
num At Risk
40
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
7
num At Risk
40
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
5
num At Risk
40
term
Aspartate aminotransferase increase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
8
num At Risk
40
term
Back pain

serious Events

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
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
40
term
Anorexia
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
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
40
term
Aspiration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
40
term
Chest pain - cardiac
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
40
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
40
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
40
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
40
term
Fatigue
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
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
13
num At Risk
40
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
40
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
40
term
Flu like symptoms
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
40
term
Hip fracture
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
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
40
term
Hyponatremia

time Frame

Up to 5 years.

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

Preserved source evidence · Not medical advice