NCT02561273 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma · Source last updated 2023-12-13

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: Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (10 mg Lenalidomide) Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant	14 / 39	32 / 39	9 / 39
Treatment (15 mg Lenalidomide) Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant	2 / 4	4 / 4	1 / 4

Group identifiers: EG000: Treatment (10 mg Lenalidomide) · EG001: Treatment (15 mg Lenalidomide)

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
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
14
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
4
term
Febrile neutropenia
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
39
group Id
EG001
num Affected
0
num At Risk
4
term
platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
4
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
4
term
diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
hypotension
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
39
group Id
EG001
num Affected
0
num At Risk
4
term
pleural effusion
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
39
group Id
EG001
num Affected
0
num At Risk
4
term
White blood cells decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
Appendicitis

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
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
32
num At Risk
39
group Id
EG001
num Affected
4
num At Risk
4
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
26
num At Risk
39
group Id
EG001
num Affected
3
num At Risk
4
term
White blood cell decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
25
num At Risk
39
group Id
EG001
num Affected
4
num At Risk
4
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
23
num At Risk
39
group Id
EG001
num Affected
2
num At Risk
4
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
23
num At Risk
39
group Id
EG001
num Affected
3
num At Risk
4
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
20
num At Risk
39
group Id
EG001
num Affected
4
num At Risk
4
term
Lymphocyte count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
18
num At Risk
39
group Id
EG001
num Affected
3
num At Risk
4
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
17
num At Risk
39
group Id
EG001
num Affected
2
num At Risk
4
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
16
num At Risk
39
group Id
EG001
num Affected
2
num At Risk
4
term
diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
16
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
4
term
peripheral sensory neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
13
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
4
term
constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
11
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
dizziness

Complete source fields

event Groups

deaths Num Affected
9
deaths Num At Risk
39
description
Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant
id
EG000
other Num Affected
32
other Num At Risk
39
serious Num Affected
14
serious Num At Risk
39
title
Treatment (10 mg Lenalidomide)
deaths Num Affected
1
deaths Num At Risk
4
description
Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Treatment (15 mg Lenalidomide)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
32
num At Risk
39
group Id
EG001
num Affected
4
num At Risk
4
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
26
num At Risk
39
group Id
EG001
num Affected
3
num At Risk
4
term
White blood cell decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
25
num At Risk
39
group Id
EG001
num Affected
4
num At Risk
4
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
23
num At Risk
39
group Id
EG001
num Affected
2
num At Risk
4
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
23
num At Risk
39
group Id
EG001
num Affected
3
num At Risk
4
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
20
num At Risk
39
group Id
EG001
num Affected
4
num At Risk
4
term
Lymphocyte count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
18
num At Risk
39
group Id
EG001
num Affected
3
num At Risk
4
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
17
num At Risk
39
group Id
EG001
num Affected
2
num At Risk
4
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
16
num At Risk
39
group Id
EG001
num Affected
2
num At Risk
4
term
diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
16
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
4
term
peripheral sensory neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
13
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
4
term
constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
11
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
dizziness

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
14
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
4
term
Febrile neutropenia
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
39
group Id
EG001
num Affected
0
num At Risk
4
term
platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
4
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
4
term
diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
hypotension
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
39
group Id
EG001
num Affected
0
num At Risk
4
term
pleural effusion
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
39
group Id
EG001
num Affected
0
num At Risk
4
term
White blood cells decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
4
term
Appendicitis

time Frame

Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)

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Preserved source evidence · Not medical advice