Trial Outcomes & Findings for Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck (NCT NCT01458392)
NCT ID: NCT01458392
Last Updated: 2022-10-05
Results Overview
ORR is defined as the proportion of patients who met criteria for complete response or partial response. Patients were evaluable for ORR if they had at least one measurable lesion at baseline and at least one disease assessment after baseline. RECIST version 1.1 was used to evaluate efficacy. In addition, patients who developed clinical or radiological progression of disease prior to the scheduled tumor assessment were also considered evaluable for response. The response rate was estimated as the proportion of patients evaluable for response who meet the criteria for complete (CR) and partial response (PR). Per RECIST v1.1 for target lesions and assessed by MRI: complete response (CR), disappearance of all target lesions; partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR + PR.
COMPLETED
PHASE2
46 participants
Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years.
2022-10-05
Participant Flow
Participant milestones
| Measure |
Dalantercept 80 mg
Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
|
Dalantercept 0.6 mg/kg
Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
13
|
31
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
13
|
31
|
Reasons for withdrawal
| Measure |
Dalantercept 80 mg
Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
|
Dalantercept 0.6 mg/kg
Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
11
|
22
|
|
Overall Study
At the discretion of the sponsor
|
0
|
2
|
7
|
|
Overall Study
Patient unwilling to comply with protoco
|
0
|
0
|
2
|
Baseline Characteristics
Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck
Baseline characteristics by cohort
| Measure |
Dalantercept 80 mg
n=2 Participants
Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
|
Dalantercept 0.6 mg/kg
n=13 Participants
Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
n=31 Participants
Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 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
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
34 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
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
13 participants
n=7 Participants
|
31 participants
n=5 Participants
|
46 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years.Population: The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population. 40 received at least one dose of study drug in either the 0.6 mg/kg or 1.2 mg/kg dose groups and had at least one on-treatment tumor assessment.
ORR is defined as the proportion of patients who met criteria for complete response or partial response. Patients were evaluable for ORR if they had at least one measurable lesion at baseline and at least one disease assessment after baseline. RECIST version 1.1 was used to evaluate efficacy. In addition, patients who developed clinical or radiological progression of disease prior to the scheduled tumor assessment were also considered evaluable for response. The response rate was estimated as the proportion of patients evaluable for response who meet the criteria for complete (CR) and partial response (PR). Per RECIST v1.1 for target lesions and assessed by MRI: complete response (CR), disappearance of all target lesions; partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR + PR.
Outcome measures
| Measure |
Dalantercept 0.6 mg/kg
n=13 Participants
Subcutaneous 0.6-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
n=27 Participants
Subcutaneous 1.2-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 participants
Interval 0.0 to 0.0
|
2 participants
Interval 0.9 to 24.3
|
—
|
SECONDARY outcome
Timeframe: Adverse events captured from first dose of dalantercept through 30 days after last dose of dalantercept.Number of participants with at least one adverse event as a measure of safety and tolerability.
Outcome measures
| Measure |
Dalantercept 0.6 mg/kg
n=2 Participants
Subcutaneous 0.6-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
n=13 Participants
Subcutaneous 1.2-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
n=31 Participants
Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
|
|---|---|---|---|
|
Safety and Tolerability
|
2 participants
|
13 participants
|
31 participants
|
SECONDARY outcome
Timeframe: Up to 43 days from initiation of treatment.Population: The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol was amended to incorporate weight-based dosing for the remainder of the study population. 2 patients in the 0.6-mg/kg and 6 in the 1.2-mg/kg cohort had less than 2 measurable serum dalantercept concentrations and were excluded from PK analysis.
Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is AUC0-t (cycle 1).
Outcome measures
| Measure |
Dalantercept 0.6 mg/kg
n=12 Participants
Subcutaneous 0.6-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
n=26 Participants
Subcutaneous 1.2-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
|
|---|---|---|---|
|
Dalantercept Serum Concentration After Single and Multiple Doses
|
32992 ng*day/mL
Geometric Coefficient of Variation 35.1
|
69572 ng*day/mL
Geometric Coefficient of Variation 44.7
|
—
|
SECONDARY outcome
Timeframe: Up to 43 days from initiation of treatment.Population: The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol was amended to incorporate weight-based dosing for the remainder of the study population. 2 patients in the 0.6-mg/kg and 6 in the 1.2-mg/kg cohort had less than 2 measurable serum dalantercept concentrations and were excluded from PK analysis.
Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is Cmax (cycle 1).
Outcome measures
| Measure |
Dalantercept 0.6 mg/kg
n=12 Participants
Subcutaneous 0.6-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
n=26 Participants
Subcutaneous 1.2-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
|
|---|---|---|---|
|
Dalantercept Serum Concentration After Single and Multiple Doses
|
2446 ng/mL
Geometric Coefficient of Variation 35.1
|
5336 ng/mL
Geometric Coefficient of Variation 37.8
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years.Population: The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population.
PFS is defined as the date of the first dose to the first observation of disease progression (according to RECIST v.1.1) or death due to any cause. Progression is defined using RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Dalantercept 0.6 mg/kg
n=13 Participants
Subcutaneous 0.6-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
n=31 Participants
Subcutaneous 1.2-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
5.8 weeks
Interval 5.6 to 11.9
|
6.1 weeks
Interval 5.7 to 11.7
|
—
|
SECONDARY outcome
Timeframe: Survival captured until death or at a minimum 1 year from first dose of dalantercept.Population: The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population.
OS is calculated as the number of months from date of the first dose to the date of death. The last patient treated will be followed for overall survival for 1 year following treatment initiation.
Outcome measures
| Measure |
Dalantercept 0.6 mg/kg
n=13 Participants
Subcutaneous 0.6-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
n=31 Participants
Subcutaneous 1.2-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
|
|---|---|---|---|
|
Overall Survival (OS)
|
30.9 weeks
Interval 13.6 to 45.6
|
41.3 weeks
Interval 23.9 to 69.4
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years.Population: The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population. 40 received at least one dose of study drug in either the 0.6 mg/kg or 1.2 mg/kg dose groups and had at least one on-treatment tumor assessment.
Disease control rate will be estimated as the proportion of patients evaluable for response who meet the criteria for complete response, partial response, or stable disease.
Outcome measures
| Measure |
Dalantercept 0.6 mg/kg
n=13 Participants
Subcutaneous 0.6-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
n=27 Participants
Subcutaneous 1.2-mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
|
|---|---|---|---|
|
Disease Control Rate
|
30.8 percentage of participants
Interval 9.1 to 61.4
|
44.4 percentage of participants
Interval 25.5 to 64.7
|
—
|
Adverse Events
Dalantercept 80 mg
Dalantercept 0.6 mg/kg
Dalantercept 1.2 mg/kg
Serious adverse events
| Measure |
Dalantercept 80 mg
n=2 participants at risk
Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
|
Dalantercept 0.6 mg/kg
n=13 participants at risk
Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
n=31 participants at risk
Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue cancer metastatic
|
50.0%
1/2
|
0.00%
0/13
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2
|
7.7%
1/13
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/2
|
0.00%
0/13
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/2
|
0.00%
0/13
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
General disorders
Disease progression
|
0.00%
0/2
|
7.7%
1/13
|
6.5%
2/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.00%
0/2
|
0.00%
0/13
|
3.2%
1/31
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2
|
0.00%
0/13
|
3.2%
1/31
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/2
|
0.00%
0/13
|
3.2%
1/31
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/2
|
0.00%
0/13
|
3.2%
1/31
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/2
|
0.00%
0/13
|
3.2%
1/31
|
Other adverse events
| Measure |
Dalantercept 80 mg
n=2 participants at risk
Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
|
Dalantercept 0.6 mg/kg
n=13 participants at risk
Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
|
Dalantercept 1.2 mg/kg
n=31 participants at risk
Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
|
|---|---|---|---|
|
General disorders
Fatigue
|
50.0%
1/2
|
61.5%
8/13
|
38.7%
12/31
|
|
General disorders
Oedema peripheral
|
0.00%
0/2
|
15.4%
2/13
|
35.5%
11/31
|
|
General disorders
Face oedema
|
0.00%
0/2
|
0.00%
0/13
|
16.1%
5/31
|
|
General disorders
Oedema
|
50.0%
1/2
|
15.4%
2/13
|
3.2%
1/31
|
|
General disorders
Pyrexia
|
0.00%
0/2
|
0.00%
0/13
|
12.9%
4/31
|
|
General disorders
Malaise
|
0.00%
0/2
|
7.7%
1/13
|
3.2%
1/31
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
|
General disorders
Pain
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
|
General disorders
Catheter site pain
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
General disorders
Injection site pain
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2
|
15.4%
2/13
|
16.1%
5/31
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2
|
15.4%
2/13
|
12.9%
4/31
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2
|
7.7%
1/13
|
12.9%
4/31
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2
|
0.00%
0/13
|
9.7%
3/31
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia exertional
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2
|
15.4%
2/13
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Nervous system disorders
Headache
|
50.0%
1/2
|
30.8%
4/13
|
35.5%
11/31
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2
|
0.00%
0/13
|
12.9%
4/31
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/2
|
7.7%
1/13
|
9.7%
3/31
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2
|
7.7%
1/13
|
3.2%
1/31
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2
|
15.4%
2/13
|
0.00%
0/31
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2
|
23.1%
3/13
|
6.5%
2/31
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2
|
7.7%
1/13
|
12.9%
4/31
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2
|
15.4%
2/13
|
9.7%
3/31
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2
|
7.7%
1/13
|
9.7%
3/31
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2
|
15.4%
2/13
|
6.5%
2/31
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2
|
7.7%
1/13
|
6.5%
2/31
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/2
|
7.7%
1/13
|
3.2%
1/31
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2
|
15.4%
2/13
|
51.6%
16/31
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2
|
0.00%
0/13
|
9.7%
3/31
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
50.0%
1/2
|
0.00%
0/13
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
1/2
|
7.7%
1/13
|
29.0%
9/31
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2
|
23.1%
3/13
|
16.1%
5/31
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2
|
0.00%
0/13
|
19.4%
6/31
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2
|
15.4%
2/13
|
9.7%
3/31
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2
|
7.7%
1/13
|
6.5%
2/31
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
1/2
|
0.00%
0/13
|
6.5%
2/31
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2
|
7.7%
1/13
|
9.7%
3/31
|
|
Investigations
Weight increased
|
0.00%
0/2
|
0.00%
0/13
|
12.9%
4/31
|
|
Investigations
Weight decreased
|
0.00%
0/2
|
23.1%
3/13
|
0.00%
0/31
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/2
|
7.7%
1/13
|
3.2%
1/31
|
|
Investigations
Lipase increase
|
0.00%
0/2
|
7.7%
1/13
|
3.2%
1/31
|
|
Investigations
Blood urea increased
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Investigations
Protein total decreased
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Investigations
Troponin increased
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2
|
0.00%
0/13
|
19.4%
6/31
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2
|
0.00%
0/13
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2
|
7.7%
1/13
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2
|
0.00%
0/13
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2
|
7.7%
1/13
|
3.2%
1/31
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2
|
7.7%
1/13
|
3.2%
1/31
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
|
Infections and infestations
Sinusitis
|
50.0%
1/2
|
0.00%
0/13
|
3.2%
1/31
|
|
Infections and infestations
Candidiasis
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Infections and infestations
Wound infection
|
50.0%
1/2
|
0.00%
0/13
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
50.0%
1/2
|
0.00%
0/13
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/2
|
7.7%
1/13
|
9.7%
3/31
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2
|
15.4%
2/13
|
3.2%
1/31
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2
|
7.7%
1/13
|
9.7%
3/31
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
|
Psychiatric disorders
Depression
|
0.00%
0/2
|
7.7%
1/13
|
3.2%
1/31
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2
|
7.7%
1/13
|
3.2%
1/31
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Eye disorders
Macular degeneration
|
0.00%
0/2
|
7.7%
1/13
|
0.00%
0/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2
|
7.7%
1/13
|
3.2%
1/31
|
|
Vascular disorders
Hypotension
|
0.00%
0/2
|
7.7%
1/13
|
9.7%
3/31
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
0.00%
0/2
|
0.00%
0/13
|
6.5%
2/31
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place