Trial Outcomes & Findings for Phase IIa Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRz and 4-Signaling Domains in Patients With Chemotherapy Relapsed or Refractory CD19+ Lymphomas (NCT NCT02030834)
NCT ID: NCT02030834
Last Updated: 2023-06-22
Results Overview
Responders will include those patients achieving complete response (CR), complete response unconfirmed (CRu) and partial response (PR) using anatomic imaging such as CT or MRI to assess tumor volume or, in the event of bone marrow involvement, morphologic and immunohistochemical confirmation that the bone marrow infiltrate has been cleared.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
3 months
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
Cohort A
murine CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
Cohort B
T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
Cohort C
Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
3
|
10
|
|
Overall Study
COMPLETED
|
39
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
11
|
0
|
3
|
Reasons for withdrawal
| Measure |
Cohort A
murine CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
Cohort B
T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
Cohort C
Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
|---|---|---|---|
|
Overall Study
Death
|
4
|
0
|
0
|
|
Overall Study
Manufacturing failure
|
2
|
0
|
1
|
|
Overall Study
Disease progression
|
2
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Lack of funding
|
1
|
0
|
0
|
Baseline Characteristics
Phase IIa Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRz and 4-Signaling Domains in Patients With Chemotherapy Relapsed or Refractory CD19+ Lymphomas
Baseline characteristics by cohort
| Measure |
Cohort A
n=50 Participants
murine CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
Cohort B
n=3 Participants
T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
Cohort C
n=10 Participants
Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
Total
n=63 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsResponders will include those patients achieving complete response (CR), complete response unconfirmed (CRu) and partial response (PR) using anatomic imaging such as CT or MRI to assess tumor volume or, in the event of bone marrow involvement, morphologic and immunohistochemical confirmation that the bone marrow infiltrate has been cleared.
Outcome measures
| Measure |
Cohort A
n=39 Participants
murine CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
Cohort B
n=3 Participants
T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
Cohort C
n=7 Participants
Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
|---|---|---|---|
|
Number of Subjects With an Overall Response (i.e. Either Complete Response or Partial Response) Evaluated at Three Months Post Infusion.
|
24 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Cohort A
Serious events: 32 serious events
Other events: 39 other events
Deaths: 5 deaths
Cohort B
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort C
Serious events: 5 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort A
n=50 participants at risk
murine CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
Cohort B
n=3 participants at risk
T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
Cohort C
n=10 participants at risk
Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.0%
3/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
2.0%
1/50 • 2 years
|
66.7%
2/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Eye disorders
Eye disorders - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
General disorders
Fever
|
12.0%
6/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
General disorders
Pain
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Immune system disorders
Allergic reaction
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Immune system disorders
Cytokine release syndrome
|
40.0%
20/50 • 2 years
|
66.7%
2/3 • 2 years
|
40.0%
4/10 • 2 years
|
|
Infections and infestations
Enterocolitis infectious
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Lung infection
|
6.0%
3/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Sepsis
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Sinusitis
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Nervous system disorders
Encephalopathy
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Vascular disorders
Hypotension
|
4.0%
2/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
Other adverse events
| Measure |
Cohort A
n=50 participants at risk
murine CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
Cohort B
n=3 participants at risk
T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
Cohort C
n=10 participants at risk
Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19
CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
|
|---|---|---|---|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
6.0%
3/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
28.0%
14/50 • 2 years
|
33.3%
1/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Cardiac disorders
Cardiac arrest
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
16.0%
8/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Endocrine disorders
Hypothyroidism
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Eye disorders
Blurred vision
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Eye disorders
Conjunctivitis
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Eye disorders
Eye disorders - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Eye disorders
Flashing lights
|
0.00%
0/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Floaters
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Eye disorders
Optic nerve disorder
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Eye disorders
Photophobia
|
0.00%
0/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
6/50 • 2 years
|
66.7%
2/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
18.0%
9/50 • 2 years
|
33.3%
1/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Blood and lymphatic system disorders
Diarrhea
|
16.0%
8/50 • 2 years
|
66.7%
2/3 • 2 years
|
20.0%
2/10 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/50 • 2 years
|
0.00%
0/3 • 2 years
|
20.0%
2/10 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Gastrointestinal disorders
Enterocolitis
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
14.0%
7/50 • 2 years
|
66.7%
2/3 • 2 years
|
30.0%
3/10 • 2 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
5/50 • 2 years
|
33.3%
1/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
General disorders
Chills
|
0.00%
0/50 • 2 years
|
33.3%
1/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Gastrointestinal disorders
Edema limbs
|
16.0%
8/50 • 2 years
|
33.3%
1/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Gastrointestinal disorders
Edema trunk
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
General disorders
Fatigue
|
46.0%
23/50 • 2 years
|
66.7%
2/3 • 2 years
|
30.0%
3/10 • 2 years
|
|
General disorders
Fever
|
10.0%
5/50 • 2 years
|
0.00%
0/3 • 2 years
|
20.0%
2/10 • 2 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
General disorders
Localized edema
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
6.0%
3/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
General disorders
Pain
|
14.0%
7/50 • 2 years
|
33.3%
1/3 • 2 years
|
20.0%
2/10 • 2 years
|
|
Immune system disorders
Allergic reaction
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Abdominal infection
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Bronchial infection
|
6.0%
3/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Gum infection
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Lung infection
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Infections and infestations
Mucosal infection
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Otitis media
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Papulopustular rash
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Rash pustular
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Sinusitis
|
6.0%
3/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Infections and infestations
Skin infection
|
6.0%
3/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Small intestine infection
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
10/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
8.0%
4/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Infections and infestations
Vaginal infection
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
22.0%
11/50 • 2 years
|
33.3%
1/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
2.0%
1/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
10/50 • 2 years
|
100.0%
3/3 • 2 years
|
30.0%
3/10 • 2 years
|
|
Investigations
Blood bilirubin increased
|
12.0%
6/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Investigations
CD4 lymphocytes decreased
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Investigations
Cholesterol high
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Investigations
Creatinine increased
|
12.0%
6/50 • 2 years
|
33.3%
1/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
14.0%
7/50 • 2 years
|
0.00%
0/3 • 2 years
|
20.0%
2/10 • 2 years
|
|
Investigations
Lymphocyte count increased
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Investigations
Neutrophil count decreased
|
38.0%
19/50 • 2 years
|
66.7%
2/3 • 2 years
|
50.0%
5/10 • 2 years
|
|
Investigations
Platelet count decreased
|
20.0%
10/50 • 2 years
|
66.7%
2/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Investigations
Weight gain
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Investigations
Weight loss
|
8.0%
4/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Investigations
White blood cell decreased
|
26.0%
13/50 • 2 years
|
33.3%
1/3 • 2 years
|
30.0%
3/10 • 2 years
|
|
Metabolism and nutrition disorders
Acidosis
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
8.0%
4/50 • 2 years
|
33.3%
1/3 • 2 years
|
20.0%
2/10 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.0%
11/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/50 • 2 years
|
33.3%
1/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
24.0%
12/50 • 2 years
|
33.3%
1/3 • 2 years
|
20.0%
2/10 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
32.0%
16/50 • 2 years
|
100.0%
3/3 • 2 years
|
20.0%
2/10 • 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.0%
3/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
26.0%
13/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
10/50 • 2 years
|
33.3%
1/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
36.0%
18/50 • 2 years
|
66.7%
2/3 • 2 years
|
20.0%
2/10 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
24.0%
12/50 • 2 years
|
66.7%
2/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Metabolism and nutrition disorders
Iron overload
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
6/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.0%
8/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
3/50 • 2 years
|
66.7%
2/3 • 2 years
|
20.0%
2/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Nervous system disorders
Cognitive disturbance
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Nervous system disorders
Dizziness
|
8.0%
4/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Nervous system disorders
Headache
|
22.0%
11/50 • 2 years
|
33.3%
1/3 • 2 years
|
30.0%
3/10 • 2 years
|
|
Nervous system disorders
Hydrocephalus
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Nervous system disorders
Memory impairment
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Nervous system disorders
Movements involuntary
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Nervous system disorders
Paresthesia
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Nervous system disorders
Spasticity
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Nervous system disorders
Tremor
|
6.0%
3/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Psychiatric disorders
Anxiety
|
6.0%
3/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Psychiatric disorders
Confusion
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Psychiatric disorders
Delirium
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Psychiatric disorders
Hallucinations
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Psychiatric disorders
Insomnia
|
4.0%
2/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Renal and urinary disorders
Urinary urgency
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Reproductive system and breast disorders
Genital edema
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Reproductive system and breast disorders
Perineal pain
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial stricture
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.0%
7/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.0%
3/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
2/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.0%
3/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
2/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Retinoic acid syndrome
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/50 • 2 years
|
0.00%
0/3 • 2 years
|
10.0%
1/10 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.0%
1/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Vascular disorders
Hot flashes
|
4.0%
2/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Vascular disorders
Hypertension
|
8.0%
4/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hypotension
|
12.0%
6/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Vascular disorders
Lymphedema
|
2.0%
1/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
4.0%
2/50 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/10 • 2 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/50 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/10 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place