Trial Outcomes & Findings for Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage I, Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma (NCT NCT00049036)
NCT ID: NCT00049036
Last Updated: 2014-05-14
Results Overview
Complete response defined by the International Response Criteria for Non-Hodgkin's Lymphoma
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
60 days
Results posted on
2014-05-14
Participant Flow
Participant milestones
| Measure |
EPOCH + Concurrent Rituximab
Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
|
EPOCH Followed by Rituximab
Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
55
|
|
Overall Study
COMPLETED
|
51
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage I, Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
EPOCH + Concurrent Rituximab
n=51 Participants
Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
|
EPOCH Followed by Rituximab
n=55 Participants
Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
42.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
55 participants
n=7 Participants
|
106 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: ITT
Complete response defined by the International Response Criteria for Non-Hodgkin's Lymphoma
Outcome measures
| Measure |
EPOCH + Concurrent Rituximab
n=51 Participants
Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
|
EPOCH Followed by Rituximab
n=55 Participants
Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
|
|---|---|---|
|
Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment
|
0.69 proportion
|
0.53 proportion
|
Adverse Events
EPOCH + Concurrent Rituximab
Serious events: 28 serious events
Other events: 50 other events
Deaths: 0 deaths
EPOCH Followed by Rituximab
Serious events: 27 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EPOCH + Concurrent Rituximab
n=51 participants at risk
Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
|
EPOCH Followed by Rituximab
n=55 participants at risk
Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
2/51 • Number of events 2
|
3.6%
2/55 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/51
|
3.6%
2/55 • Number of events 2
|
|
Gastrointestinal disorders
Anorexia
|
2.0%
1/51 • Number of events 2
|
0.00%
0/55
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
2.0%
1/51 • Number of events 1
|
0.00%
0/55
|
|
Immune system disorders
Autoimmune disorder
|
2.0%
1/51 • Number of events 1
|
0.00%
0/55
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/51
|
1.8%
1/55 • Number of events 2
|
|
Infections and infestations
Bone infection
|
0.00%
0/51
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.9%
2/51 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
2.0%
1/51 • Number of events 1
|
5.5%
3/55 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
2.0%
1/51 • Number of events 1
|
0.00%
0/55
|
|
Blood and lymphatic system disorders
Coagulopathy
|
2.0%
1/51 • Number of events 6
|
0.00%
0/55
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/51 • Number of events 2
|
0.00%
0/55
|
|
Nervous system disorders
Confusion
|
3.9%
2/51 • Number of events 2
|
0.00%
0/55
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/51 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • Number of events 1
|
0.00%
0/55
|
|
General disorders
Death
|
2.0%
1/51 • Number of events 1
|
0.00%
0/55
|
|
General disorders
Dehydration
|
5.9%
3/51 • Number of events 10
|
3.6%
2/55 • Number of events 3
|
|
Nervous system disorders
Depressed level of consciousness
|
2.0%
1/51 • Number of events 8
|
0.00%
0/55
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
3/51 • Number of events 3
|
9.1%
5/55 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
3.9%
2/51 • Number of events 2
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.9%
2/51 • Number of events 9
|
0.00%
0/55
|
|
General disorders
ENT exam abnormal
|
0.00%
0/51
|
3.6%
2/55 • Number of events 2
|
|
General disorders
Fatigue
|
2.0%
1/51 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.7%
7/51 • Number of events 8
|
12.7%
7/55 • Number of events 8
|
|
General disorders
Fever
|
7.8%
4/51 • Number of events 12
|
9.1%
5/55 • Number of events 7
|
|
Infections and infestations
Flu-like symptoms
|
2.0%
1/51 • Number of events 2
|
0.00%
0/55
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/51
|
1.8%
1/55 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/51 • Number of events 1
|
0.00%
0/55
|
|
General disorders
Headache
|
0.00%
0/51
|
3.6%
2/55 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
3.9%
2/51 • Number of events 6
|
1.8%
1/55 • Number of events 6
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/51
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemorrhage
|
3.9%
2/51 • Number of events 7
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
2.0%
1/51 • Number of events 3
|
0.00%
0/55
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
0.00%
0/51
|
3.6%
2/55 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.0%
1/51 • Number of events 2
|
0.00%
0/55
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/51
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
5.9%
3/51 • Number of events 3
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/51
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/51
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Infection
|
19.6%
10/51 • Number of events 20
|
10.9%
6/55 • Number of events 8
|
|
Infections and infestations
Infectious meningitis
|
2.0%
1/51 • Number of events 1
|
0.00%
0/55
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
2.0%
1/51 • Number of events 1
|
0.00%
0/55
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.8%
4/51 • Number of events 12
|
10.9%
6/55 • Number of events 9
|
|
General disorders
Lymphatic disorder
|
2.0%
1/51 • Number of events 2
|
0.00%
0/55
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.0%
1/51 • Number of events 2
|
0.00%
0/55
|
|
General disorders
Multi-organ failure
|
2.0%
1/51 • Number of events 9
|
0.00%
0/55
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.0%
1/51 • Number of events 8
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Myocardial ischemia
|
2.0%
1/51 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/51 • Number of events 1
|
7.3%
4/55 • Number of events 6
|
|
Nervous system disorders
Neurological disorder
|
0.00%
0/51
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.6%
9/51 • Number of events 15
|
16.4%
9/55 • Number of events 10
|
|
General disorders
Pain
|
2.0%
1/51 • Number of events 1
|
0.00%
0/55
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/51
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelet count decreases
|
3.9%
2/51 • Number of events 7
|
3.6%
2/55 • Number of events 4
|
|
Infections and infestations
Pneumonia
|
0.00%
0/51
|
3.6%
2/55 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/51
|
1.8%
1/55 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamation
|
2.0%
1/51 • Number of events 1
|
0.00%
0/55
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/51 • Number of events 2
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
2.0%
1/51 • Number of events 6
|
0.00%
0/55
|
|
Nervous system disorders
Seizure
|
3.9%
2/51 • Number of events 9
|
0.00%
0/55
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.9%
2/51 • Number of events 2
|
0.00%
0/55
|
|
Infections and infestations
Skin infection
|
2.0%
1/51 • Number of events 3
|
0.00%
0/55
|
|
Nervous system disorders
Syncope
|
2.0%
1/51 • Number of events 1
|
0.00%
0/55
|
|
Vascular disorders
Thrombosis
|
2.0%
1/51 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Nervous system disorders
Tremor
|
2.0%
1/51 • Number of events 1
|
0.00%
0/55
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/51
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • Number of events 1
|
5.5%
3/55 • Number of events 4
|
|
Infections and infestations
Wound infection
|
0.00%
0/51
|
1.8%
1/55 • Number of events 1
|
Other adverse events
| Measure |
EPOCH + Concurrent Rituximab
n=51 participants at risk
Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
|
EPOCH Followed by Rituximab
n=55 participants at risk
Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
|
|---|---|---|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
27.5%
14/51 • Number of events 41
|
27.3%
15/55 • Number of events 55
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
6/51 • Number of events 9
|
12.7%
7/55 • Number of events 22
|
|
Blood and lymphatic system disorders
Blood disorder
|
7.8%
4/51 • Number of events 45
|
9.1%
5/55 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.7%
7/51 • Number of events 20
|
12.7%
7/55 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
11.8%
6/51 • Number of events 9
|
12.7%
7/55 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Chills
|
15.7%
8/51 • Number of events 10
|
10.9%
6/55 • Number of events 12
|
|
Nervous system disorders
Confusion
|
9.8%
5/51 • Number of events 6
|
10.9%
6/55 • Number of events 9
|
|
Gastrointestinal disorders
Constipation
|
33.3%
17/51 • Number of events 32
|
36.4%
20/55 • Number of events 42
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.7%
8/51 • Number of events 25
|
16.4%
9/55 • Number of events 17
|
|
General disorders
Dehydration
|
11.8%
6/51 • Number of events 23
|
16.4%
9/55 • Number of events 13
|
|
Nervous system disorders
Depression
|
17.6%
9/51 • Number of events 13
|
7.3%
4/55 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
17/51 • Number of events 57
|
40.0%
22/55 • Number of events 33
|
|
Nervous system disorders
Dizziness
|
15.7%
8/51 • Number of events 9
|
12.7%
7/55 • Number of events 18
|
|
Gastrointestinal disorders
Abdominal pain
|
27.5%
14/51 • Number of events 25
|
32.7%
18/55 • Number of events 40
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increases
|
25.5%
13/51 • Number of events 30
|
34.5%
19/55 • Number of events 62
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increases
|
21.6%
11/51 • Number of events 29
|
30.9%
17/55 • Number of events 43
|
|
Immune system disorders
Allergic rhinitis
|
11.8%
6/51 • Number of events 19
|
9.1%
5/55 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.4%
16/51 • Number of events 46
|
29.1%
16/55 • Number of events 39
|
|
Gastrointestinal disorders
Anorexia
|
19.6%
10/51 • Number of events 24
|
18.2%
10/55 • Number of events 14
|
|
Nervous system disorders
Anxiety
|
21.6%
11/51 • Number of events 25
|
12.7%
7/55 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.8%
4/51 • Number of events 4
|
7.3%
4/55 • Number of events 8
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
4/51 • Number of events 4
|
7.3%
4/55 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.7%
7/51 • Number of events 24
|
18.2%
10/55 • Number of events 14
|
|
Gastrointestinal disorders
ENT examination abnormal
|
19.6%
10/51 • Number of events 22
|
16.4%
9/55 • Number of events 14
|
|
General disorders
Edema, limbs
|
2.0%
1/51 • Number of events 2
|
9.1%
5/55 • Number of events 6
|
|
General disorders
Fatigue
|
49.0%
25/51 • Number of events 58
|
41.8%
23/55 • Number of events 57
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.7%
8/51 • Number of events 9
|
16.4%
9/55 • Number of events 13
|
|
General disorders
Fever
|
45.1%
23/51 • Number of events 56
|
32.7%
18/55 • Number of events 31
|
|
Infections and infestations
Gingival infection
|
13.7%
7/51 • Number of events 9
|
5.5%
3/55 • Number of events 4
|
|
General disorders
Headache
|
41.2%
21/51 • Number of events 48
|
30.9%
17/55 • Number of events 46
|
|
Blood and lymphatic system disorders
Hemoglobin decreases
|
43.1%
22/51 • Number of events 141
|
50.9%
28/55 • Number of events 172
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
13.7%
7/51 • Number of events 12
|
3.6%
2/55 • Number of events 3
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
7.8%
4/51 • Number of events 12
|
18.2%
10/55 • Number of events 25
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
27.5%
14/51 • Number of events 64
|
29.1%
16/55 • Number of events 55
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.7%
7/51 • Number of events 23
|
16.4%
9/55 • Number of events 19
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.9%
3/51 • Number of events 12
|
9.1%
5/55 • Number of events 15
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.7%
7/51 • Number of events 25
|
25.5%
14/55 • Number of events 41
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.6%
11/51 • Number of events 26
|
20.0%
11/55 • Number of events 42
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.9%
3/51 • Number of events 8
|
7.3%
4/55 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.6%
9/51 • Number of events 23
|
14.5%
8/55 • Number of events 14
|
|
Cardiac disorders
Hypotension
|
25.5%
13/51 • Number of events 14
|
3.6%
2/55 • Number of events 2
|
|
Infections and infestations
Infection
|
31.4%
16/51 • Number of events 44
|
41.8%
23/55 • Number of events 30
|
|
General disorders
Insomnia
|
11.8%
6/51 • Number of events 13
|
23.6%
13/55 • Number of events 20
|
|
Blood and lymphatic system disorders
Leukopenia
|
41.2%
21/51 • Number of events 142
|
41.8%
23/55 • Number of events 207
|
|
General disorders
Lymphatic disorder
|
9.8%
5/51 • Number of events 10
|
10.9%
6/55 • Number of events 18
|
|
Blood and lymphatic system disorders
Lymphopenia
|
19.6%
10/51 • Number of events 91
|
18.2%
10/55 • Number of events 142
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.9%
3/51 • Number of events 12
|
5.5%
3/55 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.8%
4/51 • Number of events 9
|
20.0%
11/55 • Number of events 15
|
|
Gastrointestinal disorders
Nausea
|
60.8%
31/51 • Number of events 85
|
43.6%
24/55 • Number of events 79
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
3/51 • Number of events 4
|
10.9%
6/55 • Number of events 7
|
|
Blood and lymphatic system disorders
Neutropenia
|
54.9%
28/51 • Number of events 100
|
54.5%
30/55 • Number of events 133
|
|
General disorders
Oral pain
|
7.8%
4/51 • Number of events 13
|
3.6%
2/55 • Number of events 2
|
|
General disorders
Pain
|
11.8%
6/51 • Number of events 9
|
12.7%
7/55 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.7%
7/51 • Number of events 8
|
9.1%
5/55 • Number of events 16
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.9%
2/51 • Number of events 10
|
7.3%
4/55 • Number of events 6
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
31.4%
16/51 • Number of events 57
|
36.4%
20/55 • Number of events 76
|
|
Blood and lymphatic system disorders
Platelet count decreases
|
27.5%
14/51 • Number of events 58
|
36.4%
20/55 • Number of events 112
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
3/51 • Number of events 6
|
10.9%
6/55 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Rash desquamation
|
25.5%
13/51 • Number of events 32
|
16.4%
9/55 • Number of events 14
|
|
Cardiac disorders
Sinus tachycardia
|
13.7%
7/51 • Number of events 26
|
5.5%
3/55 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
15.7%
8/51 • Number of events 18
|
9.1%
5/55 • Number of events 26
|
|
General disorders
Sweating
|
21.6%
11/51 • Number of events 15
|
23.6%
13/55 • Number of events 29
|
|
Gastrointestinal disorders
Taste alteration
|
11.8%
6/51 • Number of events 10
|
0.00%
0/55
|
|
Vascular disorders
Thrombosis
|
5.9%
3/51 • Number of events 3
|
5.5%
3/55 • Number of events 5
|
|
Renal and urinary disorders
Urogenital disorder
|
5.9%
3/51 • Number of events 4
|
5.5%
3/55 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting
|
39.2%
20/51 • Number of events 50
|
36.4%
20/55 • Number of events 42
|
|
General disorders
Weight loss
|
13.7%
7/51 • Number of events 14
|
20.0%
11/55 • Number of events 17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60