Trial Outcomes & Findings for Study of ADXS-503 With or Without Pembro in Subjects With Metastatic Non-Small Cell Lung Cancer (NCT NCT03847519)
NCT ID: NCT03847519
Last Updated: 2024-06-04
Results Overview
The safety/tolerability of ADXS-503 monotherapy in Part A and in combination pembrolizumab in Part B was assessed by the number of patients with treatment-related adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
12 Months
Results posted on
2024-06-04
Participant Flow
Participant milestones
| Measure |
Safety Phase Part A - ADXS-503
1e8 CFU of ADXS-503, IV, every 3 weeks until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Safety Phase Part B - ADXS-503 + 200mg Pembrolizumab
5e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Efficacy Phase Part C - ADXS-503 + 200mg Pembrolizumab
1e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
14
|
3
|
|
Overall Study
COMPLETED
|
1
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
13
|
3
|
Reasons for withdrawal
| Measure |
Safety Phase Part A - ADXS-503
1e8 CFU of ADXS-503, IV, every 3 weeks until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Safety Phase Part B - ADXS-503 + 200mg Pembrolizumab
5e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Efficacy Phase Part C - ADXS-503 + 200mg Pembrolizumab
1e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
|---|---|---|---|
|
Overall Study
Death
|
5
|
8
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
3
|
2
|
Baseline Characteristics
Study of ADXS-503 With or Without Pembro in Subjects With Metastatic Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Safety Phase Part A - ADXS-503
n=7 Participants
1e8 CFU of ADXS-503, IV, every 3 weeks until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Safety Phase Part B - ADXS-503 + 200mg Pembrolizumab
n=14 Participants
5e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Efficacy Phase Part C - ADXS-503 + 200mg Pembrolizumab
n=3 Participants
1e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.7 years
n=5 Participants
|
68.3 years
n=7 Participants
|
70.7 years
n=5 Participants
|
68.2 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 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
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: All Treated Subjects Population will include subjects enrolled in the study arms A and B who received at least one dose of study medication
The safety/tolerability of ADXS-503 monotherapy in Part A and in combination pembrolizumab in Part B was assessed by the number of patients with treatment-related adverse events.
Outcome measures
| Measure |
Safety Phase Part A - ADXS-503
n=7 Participants
1e8 CFU of ADXS-503, IV, every 3 weeks until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Safety Phase Part B - ADXS-503 + 200mg Pembrolizumab
n=14 Participants
5e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
|---|---|---|
|
Safety/Tolerability of ADXS-503 Monotherapy in Part A and ADXS-503 With Pembrolizumab in Part B: Graded Per Comment Terminology Criteria for Adverse Events (CTCAE) Version 4.03
|
4 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: All Treated Subjects Population will include subjects enrolled in Part C of the study who received at least one dose of study medication
The anti-tumor activity of ADXS-503 + pembrolizumab was assessed by the objective response rate (ORR). The ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 was defined as the number of participants with objective evidence of radiologic complete response (CR: the disappearance of all target lesions) and partial response (PR: at least 30% decrease in the sum of the longest diameters of target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions) as determined from investigator response assessments. Disease Control Rates are based upon confirmed events only.
Outcome measures
| Measure |
Safety Phase Part A - ADXS-503
n=3 Participants
1e8 CFU of ADXS-503, IV, every 3 weeks until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Safety Phase Part B - ADXS-503 + 200mg Pembrolizumab
5e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
|---|---|---|
|
Preliminary Anti-tumor Activity of ADXS-503 + Pembrolizumab in Part C as Assessed by the Objective Response Rate (ORR)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All Treated Subjects Population will include subjects enrolled in Part A and B of the study who received at least one dose of study medication.
The anti-tumor activity of ADXS-503 as monotherapy or in combination with pembrolizumab was assessed by the objective response rate (ORR). The ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 was defined as the number of participants with objective evidence of radiologic complete response (CR: the disappearance of all target lesions) and partial response (PR: at least 30% decrease in the sum of the longest diameters of target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions) as determined from investigator response assessments. Disease Control Rates are based upon confirmed events only.
Outcome measures
| Measure |
Safety Phase Part A - ADXS-503
n=7 Participants
1e8 CFU of ADXS-503, IV, every 3 weeks until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Safety Phase Part B - ADXS-503 + 200mg Pembrolizumab
n=13 Participants
5e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
|---|---|---|
|
Preliminary Anti-tumor Activity of ADXS-503 Alone in Part A and ADXS-503 With Pembrolizumab in Part B as Assessed by the Objective Response Rate (ORR)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All Treated Subjects Population will include subjects enrolled in Part C of the study who received at least one dose of study medication.
The safety/tolerability of ADXS-503 in combination with pembrolizumab in Part C was assessed by the number of patients with treatment-related adverse events.
Outcome measures
| Measure |
Safety Phase Part A - ADXS-503
n=3 Participants
1e8 CFU of ADXS-503, IV, every 3 weeks until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Safety Phase Part B - ADXS-503 + 200mg Pembrolizumab
5e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
|---|---|---|
|
Safety/Tolerability of ADXS-503 With Pembrolizumab in Part C: Graded Per Comment Terminology Criteria for Adverse Events (CTCAE) Version 4.03
|
2 Participants
|
—
|
Adverse Events
Safety Phase Part A - ADXS-503
Serious events: 3 serious events
Other events: 7 other events
Deaths: 5 deaths
Safety Phase Part B - ADXS-503 + 200mg Pembrolizumab
Serious events: 2 serious events
Other events: 13 other events
Deaths: 8 deaths
Efficacy Phase Part C - ADXS-503 + 200mg Pembrolizumab
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Safety Phase Part A - ADXS-503
n=7 participants at risk
1e8 CFU of ADXS-503, IV, every 3 weeks until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Safety Phase Part B - ADXS-503 + 200mg Pembrolizumab
n=14 participants at risk
5e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Efficacy Phase Part C - ADXS-503 + 200mg Pembrolizumab
n=3 participants at risk
1e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac aneurysm
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Cardiac disorders
Pericardial effusion
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Psychiatric disorders
Generalized anxiety disorder
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
Other adverse events
| Measure |
Safety Phase Part A - ADXS-503
n=7 participants at risk
1e8 CFU of ADXS-503, IV, every 3 weeks until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Safety Phase Part B - ADXS-503 + 200mg Pembrolizumab
n=14 participants at risk
5e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
Efficacy Phase Part C - ADXS-503 + 200mg Pembrolizumab
n=3 participants at risk
1e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.6%
2/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
14.3%
2/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Cardiac disorders
Angina pectoris
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Cardiac disorders
Pericardial effusion
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Eye disorders
Dry eye
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
66.7%
2/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
14.3%
2/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
14.3%
2/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
66.7%
2/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
General disorders
Chills
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
35.7%
5/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
General disorders
Extravasation
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
General disorders
Facial pain
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
General disorders
Fatigue
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
42.9%
6/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
66.7%
2/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
General disorders
Influenza like illness
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
General disorders
Oedema peripheral
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
21.4%
3/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
General disorders
Pain
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
General disorders
Pyrexia
|
28.6%
2/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
50.0%
7/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Immune system disorders
Drug hypersensitivity
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Infections and infestations
Bacterial infection
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Infections and infestations
Ear infection fungal
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Infections and infestations
Lip infection
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Infections and infestations
Mastitis
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Investigations
Blood bilirubin increased
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Investigations
Blood creatinine increased
|
28.6%
2/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Investigations
Blood urea increased
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Investigations
Neutrophil count decreased
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Investigations
Weight decreased
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
66.7%
2/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.6%
2/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
42.9%
3/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Metabolism and nutrition disorders
Hypophagia
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
14.3%
2/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.6%
2/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
28.6%
4/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
14.3%
2/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
7.1%
1/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
14.3%
2/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
14.3%
2/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Vascular disorders
Deep vein thrombosis
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
33.3%
1/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
0.00%
0/14 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
66.7%
2/3 • 3 years
All Treated Subjects Population include subjects enrolled in the study who received at least one dose of study medication
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place