NCT00098475 · ADVERSE EVENTS

Adverse events

Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma · Source last updated 2026-08-28

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: Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (Lenalidomide, Dexamethasone) Step 1 Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.	146 / 223	222 / 223	Not reported / Not reported
Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1 Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.	112 / 220	216 / 220	Not reported / Not reported
Arm I (Lenalidomide, Dexamethasone) Step 2 Arm I patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.	1 / 4	4 / 4	Not reported / Not reported
Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2 Arm II patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.	3 / 14	14 / 14	Not reported / Not reported
Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin) Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.	2 / 4	4 / 4	Not reported / Not reported
Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin) Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.	1 / 3	3 / 3	Not reported / Not reported

Group identifiers: EG000: Arm I (Lenalidomide, Dexamethasone) Step 1 · EG001: Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1 · EG002: Arm I (Lenalidomide, Dexamethasone) Step 2 · EG003: Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2 · EG004: Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin) · EG005: Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)

Serious adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Vasculitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
223
group Id
EG001
num Affected
1
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Supraventricular arrhythmia NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
223
group Id
EG001
num Affected
1
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Cardiac-ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Cardiac troponin T (cTnT)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
223
group Id
EG001
num Affected
4
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
223
group Id
EG001
num Affected
2
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
3
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Left ventricular diastolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Pulmonary hypertension

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
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
132
num At Risk
223
group Id
EG001
num Affected
136
num At Risk
220
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
10
num At Risk
14
group Id
EG004
num Affected
3
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
3
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
23
num At Risk
223
group Id
EG001
num Affected
12
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Fever w/o neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
76
num At Risk
223
group Id
EG001
num Affected
84
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
14
group Id
EG004
num Affected
2
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
3
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
21
num At Risk
223
group Id
EG001
num Affected
18
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
3
term
Sweating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
30
num At Risk
223
group Id
EG001
num Affected
17
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Weight gain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
18
num At Risk
223
group Id
EG001
num Affected
13
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Weight loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
223
group Id
EG001
num Affected
3
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
3
term
Dry skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
223
group Id
EG001
num Affected
13
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Flushing
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
15
num At Risk
223
group Id
EG001
num Affected
32
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Pruritus/itching
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
36
num At Risk
223
group Id
EG001
num Affected
60
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
3
term
Rash/desquamation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Hand-foot reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
28
num At Risk
223
group Id
EG001
num Affected
18
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Anorexia

Complete source fields

event Groups

description
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
id
EG000
other Num Affected
222
other Num At Risk
223
serious Num Affected
146
serious Num At Risk
223
title
Arm I (Lenalidomide, Dexamethasone) Step 1
description
Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
id
EG001
other Num Affected
216
other Num At Risk
220
serious Num Affected
112
serious Num At Risk
220
title
Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1
description
Arm I patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
id
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Arm I (Lenalidomide, Dexamethasone) Step 2
description
Arm II patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
id
EG003
other Num Affected
14
other Num At Risk
14
serious Num Affected
3
serious Num At Risk
14
title
Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2
description
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
id
EG004
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)
description
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
id
EG005
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
132
num At Risk
223
group Id
EG001
num Affected
136
num At Risk
220
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
10
num At Risk
14
group Id
EG004
num Affected
3
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
3
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
23
num At Risk
223
group Id
EG001
num Affected
12
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Fever w/o neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
76
num At Risk
223
group Id
EG001
num Affected
84
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
14
group Id
EG004
num Affected
2
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
3
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
21
num At Risk
223
group Id
EG001
num Affected
18
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
3
term
Sweating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
30
num At Risk
223
group Id
EG001
num Affected
17
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Weight gain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
18
num At Risk
223
group Id
EG001
num Affected
13
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Weight loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
223
group Id
EG001
num Affected
3
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
3
term
Dry skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
223
group Id
EG001
num Affected
13
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Flushing
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
15
num At Risk
223
group Id
EG001
num Affected
32
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Pruritus/itching
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
36
num At Risk
223
group Id
EG001
num Affected
60
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
3
term
Rash/desquamation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Hand-foot reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
28
num At Risk
223
group Id
EG001
num Affected
18
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Anorexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Vasculitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
223
group Id
EG001
num Affected
1
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Supraventricular arrhythmia NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
223
group Id
EG001
num Affected
1
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Cardiac-ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Cardiac troponin T (cTnT)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
223
group Id
EG001
num Affected
4
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
223
group Id
EG001
num Affected
2
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
3
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Left ventricular diastolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
3
term
Pulmonary hypertension

time Frame

Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.

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Preserved source evidence · Not medical advice