Trial Outcomes & Findings for Talimogene Laherparepvec in Patients With Unresectable Pancreatic Cancer (NCT NCT00402025)
NCT ID: NCT00402025
Last Updated: 2016-04-15
Results Overview
A serious adverse event is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important and significant medical event that, based upon appropriate medical judgment, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed above.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
From first dose of talimogene laherparepvec until 30 days after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.
Results posted on
2016-04-15
Participant Flow
Participants were enrolled sequentially into each dose cohort.
Participant milestones
| Measure |
Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴plaque-forming units (PFU)/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
10
|
|
Overall Study
COMPLETED
|
1
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
10
|
Reasons for withdrawal
| Measure |
Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴plaque-forming units (PFU)/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
|
Overall Study
Death
|
0
|
1
|
5
|
|
Overall Study
Disease Progression
|
1
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
|
Overall Study
Participant Decision
|
0
|
0
|
1
|
Baseline Characteristics
Talimogene Laherparepvec in Patients With Unresectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL
n=3 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL
n=4 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
n=10 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 10.97 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 10.21 • n=7 Participants
|
50.8 years
STANDARD_DEVIATION 6.68 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 9.47 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 (Fully active)
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 (Restrictive but ambulatory)
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 (Ambulatory but unable to work)
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose of talimogene laherparepvec until 30 days after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.Population: ITT population
A serious adverse event is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important and significant medical event that, based upon appropriate medical judgment, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed above.
Outcome measures
| Measure |
Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL
n=3 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL
n=4 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
n=10 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
Deaths
|
1 participants
|
1 participants
|
6 participants
|
|
Number of Participants With Adverse Events
Discontinued study treatment due to adverse event
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Adverse Events
Any adverse event
|
3 participants
|
4 participants
|
10 participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
2 participants
|
3 participants
|
9 participants
|
PRIMARY outcome
Timeframe: Treatment Day 1 predose and 2, 6, 12 and 24 hours postdose, and Week 3 and 6 at (predose and 2 hours postdose.Population: ITT population
Samples of blood and urine collected before and up to 24 hours after dosing were tested for the presence of talimogene laherparepvec deoxyribonucleic acid (DNA) using a validated quantitative polymerase chain reaction (qPCR) assay.
Outcome measures
| Measure |
Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL
n=3 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL
n=4 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
n=10 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
|---|---|---|---|
|
Number of Participants With Talimogene Laherparepvec Detected in Blood and Urine
Blood
|
0 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Talimogene Laherparepvec Detected in Blood and Urine
Urine
|
1 participants
|
2 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Week 0 (Day 1, predose) and Week 3Population: ITT population with available antibody results (indicated by N)
Anti-HSV-1 antibodies were detected using an enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL
n=3 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL
n=4 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
n=10 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
|---|---|---|---|
|
Number of Participants Positive for Anti-herpes Simplex Virus-1 (HSV-1) Antibodies
Baseline (predose) (N= 3, 3, 8)
|
2 participants
|
3 participants
|
6 participants
|
|
Number of Participants Positive for Anti-herpes Simplex Virus-1 (HSV-1) Antibodies
Week 3 (N=3, 3, 6)
|
3 participants
|
3 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 6, 12 and 18Population: ITT population with available data at each time point (indicated by "N").
Spiral computed tomography (CT) scans were performed to assess tumors at screening and at Weeks 6, 12 and 18 after the initial dose.
Outcome measures
| Measure |
Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL
n=3 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL
n=4 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
n=10 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
|---|---|---|---|
|
Change From Baseline in Sum of Longest Diameters of Injected Tumors
Week 6 (N=2, 1, 4)
|
2.5 mm
Standard Deviation 3.54
|
18.0 mm
Standard Deviation NA
Could not be calculated due to a sample size = 1
|
-3.3 mm
Standard Deviation 12.42
|
|
Change From Baseline in Sum of Longest Diameters of Injected Tumors
Week 12 (N=1, 1, 0)
|
0.0 mm
Standard Deviation NA
Could not be calculated due to a sample size = 1
|
18.0 mm
Standard Deviation NA
Could not be calculated due to a sample size = 1
|
NA mm
Standard Deviation NA
Could not be calculated due to a sample size = 0
|
|
Change From Baseline in Sum of Longest Diameters of Injected Tumors
Week 18 (N=2, 2, 1)
|
11.5 mm
Standard Deviation 9.19
|
25.5 mm
Standard Deviation 10.61
|
37.0 mm
Standard Deviation NA
Could not be calculated due to a sample size = 1
|
SECONDARY outcome
Timeframe: Every 6 weeks until 12 weeks after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.Population: ITT population
Tumor response was assessed via CT scan by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 guidelines. Objective response is defined as a complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions, normalization of tumor marker level and no new lesions and with confirmation no less than 4 weeks after the criteria for CR is first met. PR: At least a 30% decrease in the sum of longest diameters of target lesions taking as reference the baseline sum of the longest diameters, absence of non-target lesion progression, and no new lesions. These criteria must be confirmed no less than 4 weeks after they are first met.
Outcome measures
| Measure |
Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL
n=3 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL
n=4 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
n=10 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
|---|---|---|---|
|
Number of Participants With Overall Objective Response
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 3 and 6Population: ITT population with available VAS data; this assessment was added in the third protocol amendment and change from baseline could only be assessed for participants in cohort 3.
Pain was assessed by the participant using a validated Visual Analog Scale (VAS) pain assessment instrument. A single 10-cm line was used with the leftmost end (0 cm) representing "no pain" and the rightmost end (10 cm) representing "worst pain". The distance was measured from the leftmost part of the scale to the mark made by the participant indicating pain level.
Outcome measures
| Measure |
Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
n=6 Participants
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
|---|---|---|---|
|
Change From Baseline in Pain Intensity
Week 6 (N=0, 0, 4)
|
—
|
—
|
2.575 cm
Standard Deviation 3.305
|
|
Change From Baseline in Pain Intensity
Week 3 (N=0, 0, 6)
|
—
|
—
|
1.250 cm
Standard Deviation 2.456
|
Adverse Events
Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
Serious events: 9 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL
n=3 participants at risk
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL
n=4 participants at risk
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
n=10 participants at risk
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ASCITES
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
CHEST PAIN
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
BACTERAEMIA
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC PAIN
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
SUPERIOR MESENTERIC ARTERY SYNDROME
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL
n=3 participants at risk
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL
n=4 participants at risk
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL
n=10 participants at risk
Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
2/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
SPLENOMEGALY
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
DRY EYE
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
60.0%
6/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ANORECTAL DISORDER
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ASCITES
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
5/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
5/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DIARRHOEA
|
66.7%
2/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
FLATULENCE
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
GASTROINTESTINAL OEDEMA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
NAUSEA
|
66.7%
2/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.0%
4/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
STEATORRHOEA
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
STOMACH DISCOMFORT
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
ASTHENIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
CATHETER RELATED COMPLICATION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
CHEST PAIN
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
CHILLS
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
FATIGUE
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
OEDEMA PERIPHERAL
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
PAIN
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
PYREXIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
BILE DUCT OBSTRUCTION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
BILE DUCT STENOSIS
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
JAUNDICE
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
SEASONAL ALLERGY
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
ABDOMINAL INFECTION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
CANDIDIASIS
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
INFECTION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
AMMONIA INCREASED
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
BLOOD AMYLASE INCREASED
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
BLOOD CREATINE INCREASED
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
LIPASE INCREASED
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
66.7%
2/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.0%
4/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
HEADACHE
|
33.3%
1/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
SYNCOPE VASOVAGAL
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
HALLUCINATION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
HERNIA REPAIR
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/3 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From first dose until study discontinuation; the median (minimum, maximum) duration of time in the study was 13.0 (6.0, 32.1) weeks, 5.5 (0.1, 21.0) weeks and 3.1 (0.1,16.1) weeks in each treatment group respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen, Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER