Trial Outcomes & Findings for Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors (NCT NCT04383210)
NCT ID: NCT04383210
Last Updated: 2025-04-03
Results Overview
Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1, for seribantumab monotherapy (3,000 mg QW) in patients with centrally confirmed NRG1 fusion.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2025-04-03
Participant Flow
Participant milestones
| Measure |
Cohort 1
Enrolled 36 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
Cohort 2
Enrolled 11 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
Cohort 3
Enrolled 7 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
11
|
7
|
|
Overall Study
COMPLETED
|
36
|
11
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1
n=36 Participants
Enrolled 36 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
Cohort 2
n=11 Participants
Enrolled 11 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
Cohort 3
n=7 Participants
Enrolled 7 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Age, Continuous
|
61 years
n=99 Participants
|
59 years
n=107 Participants
|
66 years
n=206 Participants
|
62 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=99 Participants
|
9 participants
n=107 Participants
|
6 participants
n=206 Participants
|
47 participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Among the 36 patients enrolled in Cohort 1, 29 of 36 patients met criteria (criteria includes centrally confirmed NRG1 fusion status and patient received 3,000 mg QW dosing) to be included in the primary efficacy population and were evaluable for investigator assessed response per RECIST v1.1. In Cohorts 2 and 3, one patient in each cohort was not evaluable for investigator assessed response per RECIST v1.1.
Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1, for seribantumab monotherapy (3,000 mg QW) in patients with centrally confirmed NRG1 fusion.
Outcome measures
| Measure |
Cohort 1
n=29 Participants
Enrolled 36 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
Cohort 2
n=10 Participants
Enrolled 11 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
Cohort 3
n=6 Participants
Enrolled 7 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
|---|---|---|---|
|
Objective Response Rate
|
10 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Cohort 1
Serious events: 17 serious events
Other events: 35 other events
Deaths: 21 deaths
Cohort 2
Serious events: 6 serious events
Other events: 11 other events
Deaths: 8 deaths
Cohort 3
Serious events: 4 serious events
Other events: 7 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Cohort 1
n=36 participants at risk
Enrolled 36 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
Cohort 2
n=11 participants at risk
Enrolled 11 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
Cohort 3
n=7 participants at risk
Enrolled 7 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
8.3%
3/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Infections and infestations
COVID-19 pneumonia
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Infections and infestations
Kidney Infection
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Infections and infestations
Sepsis
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Nervous system disorders
Carotid artery insufficiency
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Nervous system disorders
Cerebrovascular accident
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Nervous system disorders
Encephalopathy
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Nervous system disorders
Hypersensitive encephalopathy
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Nervous system disorders
Presyncope
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Nervous system disorders
Seizure
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Gastrointestinal disorders
Ascites
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
5.6%
2/36 • 3 years, 4 months
|
18.2%
2/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
2/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.6%
2/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Cardiac disorders
Arrythmia
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Cardiac disorders
Sinus tachycardia
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Investigations
Liver function test increase
|
0.00%
0/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Vascular disorders
Hypertension
|
2.8%
1/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
Other adverse events
| Measure |
Cohort 1
n=36 participants at risk
Enrolled 36 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
Cohort 2
n=11 participants at risk
Enrolled 11 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
Cohort 3
n=7 participants at risk
Enrolled 7 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy.
Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.
Seribantumab: Anti-HER3 monoclonal antibody
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
63.9%
23/36 • 3 years, 4 months
|
36.4%
4/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Gastrointestinal disorders
Nausea
|
47.2%
17/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
28.6%
2/7 • 3 years, 4 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
19.4%
7/36 • 3 years, 4 months
|
18.2%
2/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
6/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
28.6%
2/7 • 3 years, 4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
6/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Gastrointestinal disorders
Constipation
|
16.7%
6/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
4/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
General disorders
Fatigue
|
55.6%
20/36 • 3 years, 4 months
|
36.4%
4/11 • 3 years, 4 months
|
42.9%
3/7 • 3 years, 4 months
|
|
General disorders
Pyrexia
|
5.6%
2/36 • 3 years, 4 months
|
27.3%
3/11 • 3 years, 4 months
|
28.6%
2/7 • 3 years, 4 months
|
|
General disorders
Non-cardiac chest pain
|
11.1%
4/36 • 3 years, 4 months
|
18.2%
2/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
General disorders
Peripheral edema
|
11.1%
4/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
6/36 • 3 years, 4 months
|
27.3%
3/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
4/36 • 3 years, 4 months
|
18.2%
2/11 • 3 years, 4 months
|
42.9%
3/7 • 3 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
6/36 • 3 years, 4 months
|
18.2%
2/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
3/36 • 3 years, 4 months
|
27.3%
3/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
7/36 • 3 years, 4 months
|
27.3%
3/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
8/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
3/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
13.9%
5/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
13.9%
5/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.4%
7/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
6/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
4/36 • 3 years, 4 months
|
0.00%
0/11 • 3 years, 4 months
|
28.6%
2/7 • 3 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
3/36 • 3 years, 4 months
|
18.2%
2/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
9/36 • 3 years, 4 months
|
18.2%
2/11 • 3 years, 4 months
|
42.9%
3/7 • 3 years, 4 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.2%
8/36 • 3 years, 4 months
|
36.4%
4/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.8%
10/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
2/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
28.6%
2/7 • 3 years, 4 months
|
|
Nervous system disorders
Headache
|
25.0%
9/36 • 3 years, 4 months
|
54.5%
6/11 • 3 years, 4 months
|
14.3%
1/7 • 3 years, 4 months
|
|
Nervous system disorders
Dizziness
|
19.4%
7/36 • 3 years, 4 months
|
9.1%
1/11 • 3 years, 4 months
|
0.00%
0/7 • 3 years, 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60