NCT02322320 · ADVERSE EVENTS

Adverse events

Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT) · Source last updated 2020-05-11

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: 22 months post-enrollment to BMT CTN 07LT
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tandem Auto Transplant Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.	6 / 98	0 / 98	4 / 98
RVD Consolidation Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.	10 / 86	0 / 86	4 / 86
Lenalidomide Maintenance Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.	6 / 89	0 / 89	2 / 89

Group identifiers: EG000: Tandem Auto Transplant · EG001: RVD Consolidation · EG002: Lenalidomide Maintenance

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
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
89
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
98
num Events
1
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
0
num At Risk
89
num Events
0
term
Supraventricular tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
89
num Events
2
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
89
num Events
1
term
Cholecystitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
89
num Events
0
term
Cervical vertebral fracture
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
1
num At Risk
89
num Events
1
term
Subdural haematoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
89
num Events
0
term
Liver function test increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
89
num Events
0
term
Acute lymphocytic leukaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
98
num Events
1
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
0
num At Risk
89
num Events
0
term
Acute promyelocytic leukaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
89
num Events
1
term
B precursor type acute leukaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
89
num Events
1
term
B-cell type acute leukaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
89
num Events
0
term
Breast cancer

Other reported adverse events

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

Complete source fields

event Groups

deaths Num Affected
4
deaths Num At Risk
98
description
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
id
EG000
other Num Affected
0
other Num At Risk
98
serious Num Affected
6
serious Num At Risk
98
title
Tandem Auto Transplant
deaths Num Affected
4
deaths Num At Risk
86
description
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
id
EG001
other Num Affected
0
other Num At Risk
86
serious Num Affected
10
serious Num At Risk
86
title
RVD Consolidation
deaths Num Affected
2
deaths Num At Risk
89
description
Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
id
EG002
other Num Affected
0
other Num At Risk
89
serious Num Affected
6
serious Num At Risk
89
title
Lenalidomide Maintenance

frequency Threshold

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
89
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
98
num Events
1
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
0
num At Risk
89
num Events
0
term
Supraventricular tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
89
num Events
2
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
89
num Events
1
term
Cholecystitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
89
num Events
0
term
Cervical vertebral fracture
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
1
num At Risk
89
num Events
1
term
Subdural haematoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
89
num Events
0
term
Liver function test increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
89
num Events
0
term
Acute lymphocytic leukaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
98
num Events
1
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
0
num At Risk
89
num Events
0
term
Acute promyelocytic leukaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
89
num Events
1
term
B precursor type acute leukaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
89
num Events
1
term
B-cell type acute leukaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
98
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
89
num Events
0
term
Breast cancer

time Frame

22 months post-enrollment to BMT CTN 07LT

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

Preserved source evidence · Not medical advice