Trial Outcomes & Findings for Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic Cancer (NCT NCT00408434)
NCT ID: NCT00408434
Last Updated: 2020-10-19
Results Overview
Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions). Objective response rate was defined as the sum of all CRs and PRs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Baseline up to at least 2 cycles (each cycle was 3 weeks), up to 2 years 5 months
Results posted on
2020-10-19
Participant Flow
A total of 32 participants who met all inclusion criteria and no exclusion criteria were enrolled in study from 20 November 2006 to 03 April 2009 at 2 clinic sites in the United States. Of the 32 participants enrolled, 31 participants were dosed and received treatment.
Participants received CS-7017 (0.10 mg to 1.15 mg) every 12 hours. At least 3 participants were treated at each dose level. Dose escalation occurred after at least 3 participants in the current dosing cohort completed 1 cycle of treatment (3 weeks).
Participant milestones
| Measure |
CS-7017 0.10 mg
Participants who received oral CS-7017 0.10 mg every 12 hours.
|
CS-7017 0.15 mg
Participants who received oral CS-7017 0.15 mg every 12 hours.
|
CS-7017 0.25 mg
Participants who received oral CS-7017 0.25 mg every 12 hours.
|
CS-7017 0.35 mg
Participants who received oral CS-7017 0.35 mg every 12 hours.
|
CS-7017 0.50 mg
Participants who received oral CS-7017 0.50 mg every 12 hours.
|
CS-7017 0.75 mg
Participants who received oral CS-7017 0.75 mg every 12 hours.
|
CS-7017 1.15 mg
Participants who received oral CS-7017 1.15 mg every 12 hours.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
6
|
3
|
6
|
3
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
6
|
3
|
6
|
3
|
4
|
Reasons for withdrawal
| Measure |
CS-7017 0.10 mg
Participants who received oral CS-7017 0.10 mg every 12 hours.
|
CS-7017 0.15 mg
Participants who received oral CS-7017 0.15 mg every 12 hours.
|
CS-7017 0.25 mg
Participants who received oral CS-7017 0.25 mg every 12 hours.
|
CS-7017 0.35 mg
Participants who received oral CS-7017 0.35 mg every 12 hours.
|
CS-7017 0.50 mg
Participants who received oral CS-7017 0.50 mg every 12 hours.
|
CS-7017 0.75 mg
Participants who received oral CS-7017 0.75 mg every 12 hours.
|
CS-7017 1.15 mg
Participants who received oral CS-7017 1.15 mg every 12 hours.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive disease
|
6
|
3
|
4
|
3
|
3
|
1
|
4
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
2
|
1
|
0
|
|
Overall Study
Terminated by Investigator
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic Cancer
Baseline characteristics by cohort
| Measure |
CS-7017 0.10 mg
n=6 Participants
Participants who received oral CS-7017 0.10 mg every 12 hours.
|
CS-7017 0.15 mg
n=3 Participants
Participants who received oral CS-7017 0.15 mg every 12 hours.
|
CS-7017 0.25 mg
n=6 Participants
Participants who received oral CS-7017 0.25 mg every 12 hours.
|
CS-7017 0.35 mg
n=3 Participants
Participants who received oral CS-7017 0.35 mg every 12 hours.
|
CS-7017 0.50 mg
n=6 Participants
Participants who received oral CS-7017 0.50 mg every 12 hours.
|
CS-7017 0.75 mg
n=3 Participants
Participants who received oral CS-7017 0.75 mg every 12 hours.
|
CS-7017 1.15 mg
n=4 Participants
Participants who received oral CS-7017 1.15 mg every 12 hours.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 13.7 • n=4 Participants
|
62.3 years
STANDARD_DEVIATION 8.6 • n=21 Participants
|
52.3 years
STANDARD_DEVIATION 11.1 • n=8 Participants
|
53.5 years
STANDARD_DEVIATION 7.6 • n=8 Participants
|
58.1 years
STANDARD_DEVIATION 9.4 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
29 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
3 participants
n=8 Participants
|
4 participants
n=8 Participants
|
31 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline up to at least 2 cycles (each cycle was 3 weeks), up to 2 years 5 monthsPopulation: Best overall response was assessed in the Efficacy Population.
Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions). Objective response rate was defined as the sum of all CRs and PRs.
Outcome measures
| Measure |
CS-7017 0.10 mg
n=6 Participants
Participants who received oral CS-7017 0.10 mg every 12 hours.
|
CS-7017 0.15 mg
n=3 Participants
Participants who received oral CS-7017 0.15 mg every 12 hours.
|
CS-7017 0.25 mg
n=4 Participants
Participants who received oral CS-7017 0.25 mg every 12 hours.
|
CS-7017 0.35 mg
n=3 Participants
Participants who received oral CS-7017 0.35 mg every 12 hours.
|
CS-7017 0.50 mg
n=5 Participants
Participants who received oral CS-7017 0.50 mg every 12 hours.
|
CS-7017 0.75 mg
n=3 Participants
Participants who received oral CS-7017 0.75 mg every 12 hours.
|
CS-7017 1.15 mg
n=3 Participants
Participants who received oral CS-7017 1.15 mg every 12 hours.
|
CS-7017 All Participants
n=27 Participants
All participants who received CS-7017 with doses ranging from 0.10 mg to 1.15 mg every 12 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies
Complete response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies
Partial response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies
Stable disease (SD)
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
12 Participants
|
|
Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies
Progressive disease (PD)
|
3 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
14 Participants
|
|
Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies
Objective response rate (CR+PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1.Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Population.
Area under the plasma/serum drug concentration-time curve for dosing interval (AUC\[0-tau\]), computed using the linear trapezoidal rule and area under the plasma/serum drug concentration-time curve from 0 to last time point above the quantification limit (AUC\[0-t\]) calculated using the linear trapezoidal rule were assessed.
Outcome measures
| Measure |
CS-7017 0.10 mg
n=6 Participants
Participants who received oral CS-7017 0.10 mg every 12 hours.
|
CS-7017 0.15 mg
n=3 Participants
Participants who received oral CS-7017 0.15 mg every 12 hours.
|
CS-7017 0.25 mg
n=6 Participants
Participants who received oral CS-7017 0.25 mg every 12 hours.
|
CS-7017 0.35 mg
n=3 Participants
Participants who received oral CS-7017 0.35 mg every 12 hours.
|
CS-7017 0.50 mg
n=6 Participants
Participants who received oral CS-7017 0.50 mg every 12 hours.
|
CS-7017 0.75 mg
n=3 Participants
Participants who received oral CS-7017 0.75 mg every 12 hours.
|
CS-7017 1.15 mg
n=4 Participants
Participants who received oral CS-7017 1.15 mg every 12 hours.
|
CS-7017 All Participants
All participants who received CS-7017 with doses ranging from 0.10 mg to 1.15 mg every 12 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Summary of Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies
AUC(0-tau)
|
23.05 ng*h/ml
Standard Deviation 6.11
|
32.05 ng*h/ml
Standard Deviation 7.75
|
68.33 ng*h/ml
Standard Deviation 24.61
|
59.72 ng*h/ml
Standard Deviation 32.58
|
159.2 ng*h/ml
Standard Deviation 45.10
|
159.14 ng*h/ml
Standard Deviation 126.31
|
256.3 ng*h/ml
Standard Deviation 93.31
|
—
|
|
Summary of Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies
AUC(0-12)
|
32.96 ng*h/ml
Standard Deviation 6.90
|
44.14 ng*h/ml
Standard Deviation 12.15
|
91.24 ng*h/ml
Standard Deviation 36.16
|
80.80 ng*h/ml
Standard Deviation 40.74
|
220.9 ng*h/ml
Standard Deviation 74.42
|
214.38 ng*h/ml
Standard Deviation 163.81
|
356.8 ng*h/ml
Standard Deviation 127.69
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1.Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Population.
Cmax was defined as observed maximum plasma concentration.
Outcome measures
| Measure |
CS-7017 0.10 mg
n=6 Participants
Participants who received oral CS-7017 0.10 mg every 12 hours.
|
CS-7017 0.15 mg
n=3 Participants
Participants who received oral CS-7017 0.15 mg every 12 hours.
|
CS-7017 0.25 mg
n=6 Participants
Participants who received oral CS-7017 0.25 mg every 12 hours.
|
CS-7017 0.35 mg
n=3 Participants
Participants who received oral CS-7017 0.35 mg every 12 hours.
|
CS-7017 0.50 mg
n=6 Participants
Participants who received oral CS-7017 0.50 mg every 12 hours.
|
CS-7017 0.75 mg
n=3 Participants
Participants who received oral CS-7017 0.75 mg every 12 hours.
|
CS-7017 1.15 mg
n=4 Participants
Participants who received oral CS-7017 1.15 mg every 12 hours.
|
CS-7017 All Participants
All participants who received CS-7017 with doses ranging from 0.10 mg to 1.15 mg every 12 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Summary of Pharmacokinetic Parameter Observed Maximum Plasma Concentration (Cmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies
|
4.21 ng/ml
Standard Deviation 0.93
|
5.76 ng/ml
Standard Deviation 1.53
|
12.19 ng/ml
Standard Deviation 3.00
|
12.26 ng/ml
Standard Deviation 7.10
|
26.92 ng/ml
Standard Deviation 6.36
|
27.64 ng/ml
Standard Deviation 21.44
|
44.73 ng/ml
Standard Deviation 15.05
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1.Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Population.
Outcome measures
| Measure |
CS-7017 0.10 mg
n=6 Participants
Participants who received oral CS-7017 0.10 mg every 12 hours.
|
CS-7017 0.15 mg
n=3 Participants
Participants who received oral CS-7017 0.15 mg every 12 hours.
|
CS-7017 0.25 mg
n=6 Participants
Participants who received oral CS-7017 0.25 mg every 12 hours.
|
CS-7017 0.35 mg
n=3 Participants
Participants who received oral CS-7017 0.35 mg every 12 hours.
|
CS-7017 0.50 mg
n=6 Participants
Participants who received oral CS-7017 0.50 mg every 12 hours.
|
CS-7017 0.75 mg
n=3 Participants
Participants who received oral CS-7017 0.75 mg every 12 hours.
|
CS-7017 1.15 mg
n=4 Participants
Participants who received oral CS-7017 1.15 mg every 12 hours.
|
CS-7017 All Participants
All participants who received CS-7017 with doses ranging from 0.10 mg to 1.15 mg every 12 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Summary of Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies
|
8.51 hour
Standard Deviation 3.92
|
13.78 hour
Standard Deviation 6.92
|
11.48 hour
Standard Deviation 11.30
|
12.49 hour
Standard Deviation 7.35
|
5.74 hour
Standard Deviation 2.56
|
9.08 hour
Standard Deviation 2.79
|
11.66 hour
Standard Deviation 3.45
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1.Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Population.
Tmax was defined as time of maximum plasma concentration.
Outcome measures
| Measure |
CS-7017 0.10 mg
n=6 Participants
Participants who received oral CS-7017 0.10 mg every 12 hours.
|
CS-7017 0.15 mg
n=3 Participants
Participants who received oral CS-7017 0.15 mg every 12 hours.
|
CS-7017 0.25 mg
n=6 Participants
Participants who received oral CS-7017 0.25 mg every 12 hours.
|
CS-7017 0.35 mg
n=3 Participants
Participants who received oral CS-7017 0.35 mg every 12 hours.
|
CS-7017 0.50 mg
n=6 Participants
Participants who received oral CS-7017 0.50 mg every 12 hours.
|
CS-7017 0.75 mg
n=3 Participants
Participants who received oral CS-7017 0.75 mg every 12 hours.
|
CS-7017 1.15 mg
n=4 Participants
Participants who received oral CS-7017 1.15 mg every 12 hours.
|
CS-7017 All Participants
All participants who received CS-7017 with doses ranging from 0.10 mg to 1.15 mg every 12 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Summary of Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies
|
3.00 hour
Interval 2.0 to 6.0
|
2.00 hour
Interval 1.0 to 2.0
|
1.58 hour
Interval 1.0 to 4.0
|
3.00 hour
Interval 1.0 to 3.0
|
2.00 hour
Interval 1.0 to 4.0
|
3.00 hour
Interval 2.0 to 4.0
|
2.50 hour
Interval 2.0 to 4.0
|
—
|
Adverse Events
CS-7017 0.10 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
CS-7017 0.15 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CS-7017 0.25 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
CS-7017 0.35 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
CS-7017 0.50 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
CS-7017 0.75 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CS-7017 1.15 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CS-7017 0.10 mg
n=6 participants at risk
Participants who received oral CS-7017 0.10 mg every 12 hours.
|
CS-7017 0.15 mg
n=3 participants at risk
Participants who received oral CS-7017 0.15 mg every 12 hours.
|
CS-7017 0.25 mg
n=6 participants at risk
Participants who received oral CS-7017 0.25 mg every 12 hours.
|
CS-7017 0.35 mg
n=3 participants at risk
Participants who received oral CS-7017 0.35 mg every 12 hours.
|
CS-7017 0.50 mg
n=6 participants at risk
Participants who received oral CS-7017 0.50 mg every 12 hours.
|
CS-7017 0.75 mg
n=3 participants at risk
Participants who received oral CS-7017 0.75 mg every 12 hours.
|
CS-7017 1.15 mg
n=4 participants at risk
Participants who received oral CS-7017 1.15 mg every 12 hours.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Cardiac disorders
Cardiac failure congestive
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
General disorders
Chest pain
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Fluid overloading
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Malnutrition
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma recurrent
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Nervous system disorders
Spinal cord compression
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
Other adverse events
| Measure |
CS-7017 0.10 mg
n=6 participants at risk
Participants who received oral CS-7017 0.10 mg every 12 hours.
|
CS-7017 0.15 mg
n=3 participants at risk
Participants who received oral CS-7017 0.15 mg every 12 hours.
|
CS-7017 0.25 mg
n=6 participants at risk
Participants who received oral CS-7017 0.25 mg every 12 hours.
|
CS-7017 0.35 mg
n=3 participants at risk
Participants who received oral CS-7017 0.35 mg every 12 hours.
|
CS-7017 0.50 mg
n=6 participants at risk
Participants who received oral CS-7017 0.50 mg every 12 hours.
|
CS-7017 0.75 mg
n=3 participants at risk
Participants who received oral CS-7017 0.75 mg every 12 hours.
|
CS-7017 1.15 mg
n=4 participants at risk
Participants who received oral CS-7017 1.15 mg every 12 hours.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
4/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
100.0%
6/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
66.7%
4/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
66.7%
4/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
General disorders
Fatigue
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
100.0%
6/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
100.0%
4/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
General disorders
Oedema peripheral
|
100.0%
6/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Investigations
Weight increased
|
83.3%
5/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
66.7%
4/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
75.0%
3/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
50.0%
2/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place