Trial Outcomes & Findings for A Phase 1/2 Study To Evaluate ASN002 In Relapsed/Refractory Lymphoma And Advanced Solid Tumors (NCT NCT02440685)
NCT ID: NCT02440685
Last Updated: 2023-06-07
Results Overview
Due to the early termination of the study, data for efficacy endpoints were insufficient for the planned efficacy analyses.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
51 participants
Primary outcome timeframe
First 29 days
Results posted on
2023-06-07
Participant Flow
Participant milestones
| Measure |
10 mg BID
ASN002 Dose 10 mg BID
|
20 mg BID
ASN002 20 mg BID
|
30 mg BID
ASN002 30 mg BID
|
40 mg BID
ASN002 40 mg BID
|
50 mg BID
ASN002 50 mg BID
|
75 mg BID
ASN002 75 mg BID
|
100 mg BID
ASN002 100 mg BID
|
80 mg QD
ASN002 80 mg QD
|
120 mg QD
ASN002 120 mg QD
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
4
|
7
|
15
|
5
|
7
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
4
|
7
|
15
|
5
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1/2 Study To Evaluate ASN002 In Relapsed/Refractory Lymphoma And Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
10 mg BID
n=3 Participants
ASN002 10 mg BID
|
20 mg BID
n=4 Participants
ASN002 20 mg BID
|
30 mg BID
n=3 Participants
ASN002 30 mg BID
|
40 mg BID
n=4 Participants
ASN002 40 mg BID
|
50 mg BID
n=7 Participants
ASN002 50 mg BID
|
75 mg BID
n=15 Participants
ASN002 75 mg BID
|
100 mg BID
n=5 Participants
ASN002 100 mg BID
|
80 mg QD
n=7 Participants
ASN002 80 mg QD
|
120 mg QD
n=3 Participants
ASN002 120 mg QD
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.0 years
STANDARD_DEVIATION 19.31 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 9.47 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 5.51 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 6.68 • n=4 Participants
|
62.9 years
STANDARD_DEVIATION 20.39 • n=21 Participants
|
65.1 years
STANDARD_DEVIATION 9.92 • n=8 Participants
|
63.2 years
STANDARD_DEVIATION 13.81 • n=8 Participants
|
65.6 years
STANDARD_DEVIATION 10.33 • n=24 Participants
|
74.0 years
STANDARD_DEVIATION 7.00 • n=42 Participants
|
65.2 years
STANDARD_DEVIATION 11.78 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
39 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
50 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Disease Characteristic
Lymphoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
|
Disease Characteristic
Solid tumor
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
|
Disease Characteristic
Myelofibrosis
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: First 29 daysDue to the early termination of the study, data for efficacy endpoints were insufficient for the planned efficacy analyses.
Outcome measures
| Measure |
10 mg BID
n=3 Participants
ASN002 10 mg BID
|
20 mg BID
n=4 Participants
ASN002 20 mg BID
|
30 mg BID
n=3 Participants
ASN002 30 mg BID
|
40 mg BID
n=4 Participants
ASN002 40 mg BID
|
50 mg BID
n=7 Participants
ASN002 50 mg BID
|
75 mg BID
n=15 Participants
ASN002 75 mg BID
|
100 mg BID
n=5 Participants
ASN002 100 mg BID
|
80 mg QD
n=7 Participants
ASN002 80 mg QD
|
120 mg QD
n=3 Participants
ASN002 120 mg QD
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate
Not evaluable
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
12 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Objective Response Rate
Complete response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate
Partial response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Objective Response Rate
Stable disease
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Objective Response Rate
Progressive disease
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
Adverse Events
10 mg BID
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
20 mg BID
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
30 mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
40 mg BID
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
50 mg BID
Serious events: 5 serious events
Other events: 6 other events
Deaths: 2 deaths
75 mg BID
Serious events: 10 serious events
Other events: 14 other events
Deaths: 6 deaths
100 mg BID
Serious events: 4 serious events
Other events: 5 other events
Deaths: 2 deaths
80 mg QD
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
120 mg QD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10 mg BID
n=3 participants at risk
ASN002 10 mg BID
|
20 mg BID
n=4 participants at risk
ASN002 20 mg BID
|
30 mg BID
n=3 participants at risk
ASN002 30 mg BID
|
40 mg BID
n=4 participants at risk
ASN002 40 mg BID
|
50 mg BID
n=7 participants at risk
ASN002 50 mg BID
|
75 mg BID
n=15 participants at risk
ASN002 75 mg BID
|
100 mg BID
n=5 participants at risk
ASN002 100 mg BID
|
80 mg QD
n=7 participants at risk
ASN002 80 mg QD
|
120 mg QD
n=3 participants at risk
ASN002 120 mg QD
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Disease progression
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
28.6%
2/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
3/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
40.0%
2/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
40.0%
2/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
1/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
General disorders
Chest pain
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
1/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
General disorders
Multi-organ failure
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
1/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
Other adverse events
| Measure |
10 mg BID
n=3 participants at risk
ASN002 10 mg BID
|
20 mg BID
n=4 participants at risk
ASN002 20 mg BID
|
30 mg BID
n=3 participants at risk
ASN002 30 mg BID
|
40 mg BID
n=4 participants at risk
ASN002 40 mg BID
|
50 mg BID
n=7 participants at risk
ASN002 50 mg BID
|
75 mg BID
n=15 participants at risk
ASN002 75 mg BID
|
100 mg BID
n=5 participants at risk
ASN002 100 mg BID
|
80 mg QD
n=7 participants at risk
ASN002 80 mg QD
|
120 mg QD
n=3 participants at risk
ASN002 120 mg QD
|
|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
1/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
3/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
28.6%
2/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
1/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
42.9%
3/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
5/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
42.9%
3/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
66.7%
2/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
5/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
28.6%
2/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
26.7%
4/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
28.6%
2/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
28.6%
2/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
40.0%
2/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
28.6%
2/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
40.0%
6/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
28.6%
2/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
50.0%
2/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
General disorders
Chills
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
40.0%
2/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
General disorders
Disease progression
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
28.6%
2/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
3/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
General disorders
Fatigue
|
66.7%
2/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
26.7%
4/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
40.0%
2/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
66.7%
2/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
3/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
40.0%
2/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
42.9%
3/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
100.0%
3/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
28.6%
2/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
26.7%
4/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
1/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
1/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
28.6%
2/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
26.7%
4/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
40.0%
2/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
28.6%
2/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
42.9%
3/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
1/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
General disorders
Asthenia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
General disorders
Oedema Peripheral
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
1/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
3/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Investigations
Blood creatinine increase
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
1/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
3/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
28.6%
2/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
1/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Musculoskeletal and connective tissue disorders
Arthralagia
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
1/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
25.0%
1/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
40.0%
2/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
6.7%
1/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
20.0%
1/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
33.3%
1/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/4 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
13.3%
2/15 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/5 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
14.3%
1/7 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
0.00%
0/3 • Days of duration ranged from 4 days to 280 days before early termination of the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place