Trial Outcomes & Findings for A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma (NCT NCT02811679)
NCT ID: NCT02811679
Last Updated: 2025-05-23
Results Overview
Count of participants achieving a complete or partial response according to the revised response criteria for malignant lymphoma (2014). A complete response is defined as regression of involved nodes to normal size (1.5 cm or less in their greatest transverse diameter for nodes 1.5 cm or greater before therapy). Involved nodes 1.1 - 1.5 cm in their greatest transverse diameter before treatment must have decreased to less than 1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD). For a complete response, the spleen, if enlarged before therapy on a CT scan, must also have regressed in size and must not be palpable. A partial response is defined as 50% or greater decrease in SPD of up to 6 largest dominant masses. There must also be no new sites of disease or increases in the size of the other nodes, liver, or spleen. Splenic/hepatic nodules must regress by at least 50% in SPD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
at completion of treatment (6 months)
Results posted on
2025-05-23
Participant Flow
Participant milestones
| Measure |
Blinatumomab
Blinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
Blinatumomab: Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Blinatumomab
Blinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
Blinatumomab: Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Early study closure due to slow accrual
|
3
|
Baseline Characteristics
A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Blinatumomab
n=13 Participants
Blinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
Blinatumomab: Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at completion of treatment (6 months)Count of participants achieving a complete or partial response according to the revised response criteria for malignant lymphoma (2014). A complete response is defined as regression of involved nodes to normal size (1.5 cm or less in their greatest transverse diameter for nodes 1.5 cm or greater before therapy). Involved nodes 1.1 - 1.5 cm in their greatest transverse diameter before treatment must have decreased to less than 1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD). For a complete response, the spleen, if enlarged before therapy on a CT scan, must also have regressed in size and must not be palpable. A partial response is defined as 50% or greater decrease in SPD of up to 6 largest dominant masses. There must also be no new sites of disease or increases in the size of the other nodes, liver, or spleen. Splenic/hepatic nodules must regress by at least 50% in SPD.
Outcome measures
| Measure |
Blinatumomab
n=13 Participants
Blinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
Blinatumomab: Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
|
|---|---|
|
Overall Response Rate (ORR)
|
6 Participants
|
SECONDARY outcome
Timeframe: 5 yearsProgression free survival is defined as the duration of time from start of treatment to time of documentation of disease progression according to the revised response criteria for malignant lymphoma (2014), death, or loss to follow-up. Progressive disease is defined as appearance of a new PET positive lesion greater than 1.5 cm in any axis, 50% or greater increase in the sum of the products of the greatest diameters (SPD) of more than one node, 50% or greater increase in longest diameter of a previously identified node less than 1 cm in short axis. There must also be a 50% increase from nadir in the SPD of any previous lesions.
Outcome measures
| Measure |
Blinatumomab
n=13 Participants
Blinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
Blinatumomab: Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
|
|---|---|
|
Progression Free Survival
|
4.0 months
Interval 2.6 to 33.4
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: The 5 patients who achieved a response were included in the analysis; those who did not achieve a partial response or better were excluded.
Time to response is defined as the duration of time from start of treatment to the achievement of a complete response (CR) or partial response (PR) according to the revised response criteria for malignant lymphoma (2014). A CR is defined as regression of involved nodes to normal size (1.5 cm or less in their greatest transverse diameter for nodes 1.5 cm or greater before therapy). Involved nodes 1.1 - 1.5 cm in their greatest transverse diameter before treatment must have decreased to less than 1 cm in this measure after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD). For a CR, the spleen, if enlarged before therapy on a CT scan, must also have regressed in size and must not be palpable. A PR is defined as 50% or greater decrease in SPD of up to 6 largest dominant masses. There must also be no new sites of disease or increases in the size of the other nodes, liver, or spleen. Splenic/hepatic nodules must regress by at least 50% in SPD.
Outcome measures
| Measure |
Blinatumomab
n=5 Participants
Blinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
Blinatumomab: Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
|
|---|---|
|
Time To Response Rate
|
2.8 months
Interval 2.4 to 3.4
|
SECONDARY outcome
Timeframe: 5 yearsDuration of response is defined as the time from response (complete or partial response according to the revised response criteria for malignant lymphoma 2014) to disease progression, death, or loss to follow-up.
Outcome measures
| Measure |
Blinatumomab
n=5 Participants
Blinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
Blinatumomab: Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
|
|---|---|
|
Duration of Response
|
30.0 months
Interval 11.2 to 59.8
|
SECONDARY outcome
Timeframe: 2 yearsNumber of patients who discontinued study treatment early due to one or more toxicities.
Outcome measures
| Measure |
Blinatumomab
n=13 Participants
Blinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
Blinatumomab: Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
|
|---|---|
|
Rate Patients Are Discontinued From The Drug Due to Toxicity
|
1 Participants
|
SECONDARY outcome
Timeframe: 5 yearsOverall survival is defined the duration of time from start of treatment to time of death or loss to follow up.
Outcome measures
| Measure |
Blinatumomab
n=13 Participants
Blinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
Blinatumomab: Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
|
|---|---|
|
Overall Survival
|
NA months
Median could not be estimated due to an insufficient number of events.
|
Adverse Events
Blinatumomab
Serious events: 6 serious events
Other events: 12 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Blinatumomab
n=13 participants at risk
Blinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
Blinatumomab: Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
|
|---|---|
|
Nervous system disorders
Encephalopathy
|
23.1%
3/13 • Number of events 4 • 9 months
|
|
Investigations
Neutrophil count decreased
|
15.4%
2/13 • Number of events 2 • 9 months
|
|
Metabolism and nutrition disorders
Acidosis
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Nervous system disorders
Transient ischemic attacks
|
7.7%
1/13 • Number of events 1 • 9 months
|
Other adverse events
| Measure |
Blinatumomab
n=13 participants at risk
Blinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
Blinatumomab: Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
|
|---|---|
|
Investigations
Lymphocyte count decreased
|
69.2%
9/13 • Number of events 26 • 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
92.3%
12/13 • Number of events 19 • 9 months
|
|
Investigations
Investigations - Other, specify
|
38.5%
5/13 • Number of events 15 • 9 months
|
|
General disorders
Fatigue
|
92.3%
12/13 • Number of events 14 • 9 months
|
|
General disorders
Fever
|
61.5%
8/13 • Number of events 14 • 9 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
53.8%
7/13 • Number of events 13 • 9 months
|
|
Investigations
White blood cell decreased
|
38.5%
5/13 • Number of events 13 • 9 months
|
|
Investigations
Neutrophil count decreased
|
30.8%
4/13 • Number of events 12 • 9 months
|
|
Investigations
Platelet count decreased
|
46.2%
6/13 • Number of events 11 • 9 months
|
|
Nervous system disorders
Headache
|
53.8%
7/13 • Number of events 9 • 9 months
|
|
Gastrointestinal disorders
Nausea
|
46.2%
6/13 • Number of events 7 • 9 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
23.1%
3/13 • Number of events 6 • 9 months
|
|
Psychiatric disorders
Anxiety
|
38.5%
5/13 • Number of events 5 • 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
23.1%
3/13 • Number of events 4 • 9 months
|
|
Investigations
Alkaline phosphatase increased
|
15.4%
2/13 • Number of events 4 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Number of events 4 • 9 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.4%
2/13 • Number of events 4 • 9 months
|
|
Psychiatric disorders
Insomnia
|
30.8%
4/13 • Number of events 4 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
23.1%
3/13 • Number of events 4 • 9 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
30.8%
4/13 • Number of events 4 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
3/13 • Number of events 3 • 9 months
|
|
Investigations
Creatinine increased
|
15.4%
2/13 • Number of events 3 • 9 months
|
|
Immune system disorders
Cytokine release syndrome
|
15.4%
2/13 • Number of events 3 • 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13 • Number of events 3 • 9 months
|
|
Nervous system disorders
Dizziness
|
23.1%
3/13 • Number of events 3 • 9 months
|
|
Nervous system disorders
Encephalopathy
|
23.1%
3/13 • Number of events 3 • 9 months
|
|
Injury, poisoning and procedural complications
Fall
|
15.4%
2/13 • Number of events 3 • 9 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.4%
2/13 • Number of events 3 • 9 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
15.4%
2/13 • Number of events 3 • 9 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
23.1%
3/13 • Number of events 3 • 9 months
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
7.7%
1/13 • Number of events 3 • 9 months
|
|
Nervous system disorders
Tremor
|
15.4%
2/13 • Number of events 3 • 9 months
|
|
Renal and urinary disorders
Acute kidney injury
|
15.4%
2/13 • Number of events 2 • 9 months
|
|
Eye disorders
Blurred vision
|
7.7%
1/13 • Number of events 2 • 9 months
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • Number of events 2 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
2/13 • Number of events 2 • 9 months
|
|
General disorders
Edema limbs
|
7.7%
1/13 • Number of events 2 • 9 months
|
|
Eye disorders
Eye disorders - Other, specify
|
15.4%
2/13 • Number of events 2 • 9 months
|
|
General disorders
Flu like symptoms
|
15.4%
2/13 • Number of events 2 • 9 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.7%
1/13 • Number of events 2 • 9 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.7%
1/13 • Number of events 2 • 9 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • Number of events 2 • 9 months
|
|
Vascular disorders
Hypotension
|
15.4%
2/13 • Number of events 2 • 9 months
|
|
General disorders
Localized edema
|
7.7%
1/13 • Number of events 2 • 9 months
|
|
Investigations
Lymphocyte count increased
|
7.7%
1/13 • Number of events 2 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.4%
2/13 • Number of events 2 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
15.4%
2/13 • Number of events 2 • 9 months
|
|
General disorders
Pain
|
15.4%
2/13 • Number of events 2 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
15.4%
2/13 • Number of events 2 • 9 months
|
|
Infections and infestations
Upper respiratory infection
|
15.4%
2/13 • Number of events 2 • 9 months
|
|
Infections and infestations
Urinary tract infection
|
15.4%
2/13 • Number of events 2 • 9 months
|
|
Infections and infestations
Vaginal infection
|
7.7%
1/13 • Number of events 2 • 9 months
|
|
Endocrine disorders
Adrenal insufficiency
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Investigations
Blood bilirubin increased
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Bruising
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Cardiac disorders
Chest pain - cardiac
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Nervous system disorders
Cognitive disturbance
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Confusion
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Eye disorders
Conjunctivitis
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Duodenal obstruction
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Vascular disorders
Flushing
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Reproductive system and breast disorders
Genital edema
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Vascular disorders
Hot flashes
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Eye disorders
Photophobia
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - other, specify
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Cardiac disorders
Sinus bradycardia
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Cardiac disorders
Sinus tachycardia
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Infections and infestations
Sinusitis
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Nervous system disorders
Somnolence
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Reproductive system and breast disorders
Testicular pain
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Renal and urinary disorders
Urinary incontinence
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Vascular disorders
Vasculitis
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Investigations
Weight gain
|
7.7%
1/13 • Number of events 1 • 9 months
|
|
Investigations
Weight loss
|
7.7%
1/13 • Number of events 1 • 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place