NCT01155583 · ADVERSE EVENTS

Adverse events

Low-Dose Azacitidine, Lenalidomide, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma · Source last updated 2020-11-16

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: Up to 3 years from study entry
Other-event reporting threshold: 5%

Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A (GFR>=60mL/Min) Dose Level DL 1 Azacitidine (AZA) 30mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Azacitidine/Lenalidomide/Dexamethasone Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	0 / 3	3 / 3	3 / 3
Arm A (GFR>=60mL/ Min) Dose Level 2 Azacitidine 40mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	0 / 3	1 / 3	3 / 3
Arm A (GFR>=60mL/ Min) Dose Level 3 Azacitidine 30mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	2 / 4	2 / 4	4 / 4
Arm A (GFR>=60mL/ Min) Dose Level 4 Azacitidine 40mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	2 / 6	2 / 6	5 / 6
Arm A (GFR>=60mL/ Min) Dose Level 5 Azacitidine 50mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	1 / 6	3 / 6	6 / 6
Arm B (GFR 30-59mL/Min - CKD) Dose Level -1 Azacitidine 30mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	0 / 0	0 / 0	0 / 0
Arm B (GFR 30-59mL/Min - CKD) Dose Level 1 Azacitidine 40mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week	1 / 3	1 / 3	3 / 3
Arm B (GFR 30-59mL/Min - CKD) Dose Level 2 Azacitidine 50mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week	1 / 6	4 / 6	5 / 6
Arm A or B GFR >= 30mL/ Min Expansion Dose (50 BIW) Azacitidine 50mg/m2 2x week + Lenalidomide (10mg if CKD, 25mg if non-CKD) d1-21 every 28d + Dexamethasone 40mg once a week	1 / 11	9 / 11	10 / 11

Group identifiers: EG000: Arm A (GFR>=60mL/Min) Dose Level DL 1 · EG001: Arm A (GFR>=60mL/ Min) Dose Level 2 · EG002: Arm A (GFR>=60mL/ Min) Dose Level 3 · EG003: Arm A (GFR>=60mL/ Min) Dose Level 4 · EG004: Arm A (GFR>=60mL/ Min) Dose Level 5 · EG005: Arm B (GFR 30-59mL/Min - CKD) Dose Level -1 · EG006: Arm B (GFR 30-59mL/Min - CKD) Dose Level 1 · EG007: Arm B (GFR 30-59mL/Min - CKD) Dose Level 2 · EG008: Arm A or B GFR >= 30mL/ Min Expansion Dose (50 BIW)

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 v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
1
num At Risk
11
num Events
1
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Esophagitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Skin infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
2
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Hypercalcemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Confusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Atelectasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Pleural effusion

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
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
2
group Id
EG004
num Affected
1
num At Risk
6
num Events
4
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
3
num At Risk
6
num Events
17
group Id
EG008
num Affected
3
num At Risk
11
num Events
21
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
3
num At Risk
6
num Events
4
group Id
EG008
num Affected
1
num At Risk
11
num Events
2
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
3
num At Risk
6
num Events
8
group Id
EG008
num Affected
2
num At Risk
11
num Events
4
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
2
num At Risk
6
num Events
3
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Edema limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
4
num At Risk
6
num Events
12
group Id
EG008
num Affected
2
num At Risk
11
num Events
13
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
1
num At Risk
11
num Events
1
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
2
num At Risk
6
num Events
2
group Id
EG008
num Affected
2
num At Risk
11
num Events
2
term
Injection site reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
2
group Id
EG008
num Affected
1
num At Risk
11
num Events
2
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
1
num At Risk
11
num Events
6
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
2
num At Risk
6
num Events
2
group Id
EG008
num Affected
1
num At Risk
11
num Events
2
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
3
num At Risk
6
num Events
5
group Id
EG008
num Affected
1
num At Risk
11
num Events
1
term
Creatinine increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
4
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
3
num At Risk
6
num Events
13
group Id
EG008
num Affected
2
num At Risk
11
num Events
28
term
Lymphocyte count decreased

Complete source fields

description

Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.

event Groups

deaths Num Affected
3
deaths Num At Risk
3
description
Azacitidine (AZA) 30mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Azacitidine/Lenalidomide/Dexamethasone Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Arm A (GFR>=60mL/Min) Dose Level DL 1
deaths Num Affected
3
deaths Num At Risk
3
description
Azacitidine 40mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
1
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Arm A (GFR>=60mL/ Min) Dose Level 2
deaths Num Affected
4
deaths Num At Risk
4
description
Azacitidine 30mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
id
EG002
other Num Affected
2
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Arm A (GFR>=60mL/ Min) Dose Level 3
deaths Num Affected
5
deaths Num At Risk
6
description
Azacitidine 40mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
id
EG003
other Num Affected
2
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Arm A (GFR>=60mL/ Min) Dose Level 4
deaths Num Affected
6
deaths Num At Risk
6
description
Azacitidine 50mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
id
EG004
other Num Affected
3
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
Arm A (GFR>=60mL/ Min) Dose Level 5
deaths Num Affected
0
deaths Num At Risk
0
description
Azacitidine 30mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
id
EG005
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Arm B (GFR 30-59mL/Min - CKD) Dose Level -1
deaths Num Affected
3
deaths Num At Risk
3
description
Azacitidine 40mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week
id
EG006
other Num Affected
1
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Arm B (GFR 30-59mL/Min - CKD) Dose Level 1
deaths Num Affected
5
deaths Num At Risk
6
description
Azacitidine 50mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week
id
EG007
other Num Affected
4
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
Arm B (GFR 30-59mL/Min - CKD) Dose Level 2
deaths Num Affected
10
deaths Num At Risk
11
description
Azacitidine 50mg/m2 2x week + Lenalidomide (10mg if CKD, 25mg if non-CKD) d1-21 every 28d + Dexamethasone 40mg once a week
id
EG008
other Num Affected
9
other Num At Risk
11
serious Num Affected
1
serious Num At Risk
11
title
Arm A or B GFR >= 30mL/ Min Expansion Dose (50 BIW)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
2
group Id
EG004
num Affected
1
num At Risk
6
num Events
4
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
3
num At Risk
6
num Events
17
group Id
EG008
num Affected
3
num At Risk
11
num Events
21
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
3
num At Risk
6
num Events
4
group Id
EG008
num Affected
1
num At Risk
11
num Events
2
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
3
num At Risk
6
num Events
8
group Id
EG008
num Affected
2
num At Risk
11
num Events
4
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
2
num At Risk
6
num Events
3
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Edema limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
4
num At Risk
6
num Events
12
group Id
EG008
num Affected
2
num At Risk
11
num Events
13
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
1
num At Risk
11
num Events
1
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
2
num At Risk
6
num Events
2
group Id
EG008
num Affected
2
num At Risk
11
num Events
2
term
Injection site reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
2
group Id
EG008
num Affected
1
num At Risk
11
num Events
2
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
1
num At Risk
11
num Events
6
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
2
num At Risk
6
num Events
2
group Id
EG008
num Affected
1
num At Risk
11
num Events
2
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
3
num At Risk
6
num Events
5
group Id
EG008
num Affected
1
num At Risk
11
num Events
1
term
Creatinine increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
4
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
3
num At Risk
6
num Events
13
group Id
EG008
num Affected
2
num At Risk
11
num Events
28
term
Lymphocyte count decreased

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
1
num At Risk
11
num Events
1
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Esophagitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Skin infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
2
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Hypercalcemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Confusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Atelectasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
11
num Events
0
term
Pleural effusion

time Frame

Up to 3 years from study entry

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

Preserved source evidence · Not medical advice