Trial Outcomes & Findings for A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer (NCT NCT00652366)
NCT ID: NCT00652366
Last Updated: 2015-02-11
Results Overview
Overall survival (OS) assessed from the point of randomization was defined as the time from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
467 participants
Primary outcome timeframe
Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Results posted on
2015-02-11
Participant Flow
Participant milestones
| Measure |
Gemcitabine (G) Plus (+) Erlotinib (E): Rash ≥ Grade 2
Participants began a 4 week run-in period where they received gemcitabine, 1000 milligrams per square meter (mg/m\^2), intravenously (IV), on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 milligrams (mg), orally (PO) as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Standard Dose: Rash Grade Less Than (<) 2
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 milligrams per day (mg/day), PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade ≥ 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E: No Rash Non-Eligibl
Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E: Early Drop Out
Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
106
|
75
|
71
|
179
|
36
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
106
|
75
|
71
|
179
|
36
|
Reasons for withdrawal
| Measure |
Gemcitabine (G) Plus (+) Erlotinib (E): Rash ≥ Grade 2
Participants began a 4 week run-in period where they received gemcitabine, 1000 milligrams per square meter (mg/m\^2), intravenously (IV), on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 milligrams (mg), orally (PO) as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Standard Dose: Rash Grade Less Than (<) 2
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 milligrams per day (mg/day), PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade ≥ 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E: No Rash Non-Eligibl
Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E: Early Drop Out
Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
4
|
7
|
17
|
13
|
|
Overall Study
Death
|
5
|
4
|
1
|
8
|
5
|
|
Overall Study
Lack of Efficacy
|
84
|
58
|
53
|
133
|
13
|
|
Overall Study
Violation of Selection Criteria
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Refused treatment
|
3
|
7
|
6
|
17
|
5
|
|
Overall Study
Other
|
5
|
2
|
3
|
4
|
0
|
Baseline Characteristics
A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
G+E: Rash ≥ Grade 2
n=106 Participants
Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Standard Dose: Rash Grade < 2
n=75 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=70 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E: No Rash Non-Eligible
n=179 Participants
Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E: Early Drop Out
n=36 Participants
Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
|
Total
n=466 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
Less Than (<) 65 Years
|
66 participants
n=93 Participants
|
43 participants
n=4 Participants
|
34 participants
n=27 Participants
|
97 participants
n=483 Participants
|
21 participants
n=36 Participants
|
261 participants
n=10 Participants
|
|
Age, Customized
≥ 65 Years
|
40 participants
n=93 Participants
|
32 participants
n=4 Participants
|
36 participants
n=27 Participants
|
82 participants
n=483 Participants
|
15 participants
n=36 Participants
|
205 participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
77 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
208 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
102 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
258 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.Population: Full analysis set (FAS): all randomized participants.
Overall survival (OS) assessed from the point of randomization was defined as the time from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.
Outcome measures
| Measure |
G+E Standard Dose: Rash Grade < 2
n=75 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=70 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
|---|---|---|---|
|
Percentage of Participants Who Died Assessed From Point of Randomization
|
81.3 percentage of participants
|
85.7 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.Population: FAS
OS assessed from the point of randomization was defined as the median time, in months, from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. The 95 percent (%) confidence interval (CI) was determined using Kaplan-Meier methodology.
Outcome measures
| Measure |
G+E Standard Dose: Rash Grade < 2
n=75 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=70 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
|---|---|---|---|
|
OS Assessed From Point of Randomization
|
8.4 months
Interval 6.4 to 10.0
|
7.0 months
Interval 5.8 to 8.3
|
—
|
SECONDARY outcome
Timeframe: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.Population: FAS
Progression-free survival (PFS) as assessed from the point of randomization was defined as the time from randomization to the first occurrence of progressive disease (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause. For target lesions (TLs), PD was defined as at least a 20% increase in the sum of longest diameter (SLD) of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.
Outcome measures
| Measure |
G+E Standard Dose: Rash Grade < 2
n=75 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=70 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
|---|---|---|---|
|
Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization
|
90.7 percentage of participants
|
88.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.Population: FAS
PFS assessed from the point of randomization was defined as the median time, in weeks, from randomization to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.
Outcome measures
| Measure |
G+E Standard Dose: Rash Grade < 2
n=75 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=70 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
|---|---|---|---|
|
PFS Assessed From Point of Randomization
|
19.4 weeks
Interval 16.0 to 26.9
|
15.3 weeks
Interval 11.3 to 19.1
|
—
|
SECONDARY outcome
Timeframe: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.Population: FAS
BOR was defined as a confirmed CR or PR for at least 4 weeks. CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. The 95% CI for one sample binomial was determined using Pearson-Clopper method.
Outcome measures
| Measure |
G+E Standard Dose: Rash Grade < 2
n=75 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=70 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
|---|---|---|---|
|
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST
|
14.7 percentage of participants
Interval 7.6 to 24.7
|
8.6 percentage of participants
Interval 3.2 to 17.7
|
—
|
SECONDARY outcome
Timeframe: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.Population: FAS
CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Outcome measures
| Measure |
G+E Standard Dose: Rash Grade < 2
n=75 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=70 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
|---|---|---|---|
|
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST
CR
|
0.0 percentage of participants
Interval 0.0 to 4.8
|
1.4 percentage of participants
Interval 0.0 to 7.7
|
—
|
|
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST
PR
|
14.7 percentage of participants
Interval 7.6 to 24.7
|
7.1 percentage of participants
Interval 2.4 to 15.9
|
—
|
|
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST
SD
|
58.7 percentage of participants
Interval 46.7 to 69.9
|
72.9 percentage of participants
Interval 60.9 to 82.8
|
—
|
|
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST
PD
|
25.3 percentage of participants
Interval 16.0 to 36.7
|
12.9 percentage of participants
Interval 6.1 to 23.0
|
—
|
|
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST
Missing (no response assessment)
|
1.3 percentage of participants
95% CI was not determined for missing responses.
|
5.7 percentage of participants
95% CI was not determined for missing responses.
|
—
|
SECONDARY outcome
Timeframe: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.Population: FAS
Disease control was defined as a participant with a response of CR or PR for at least 4 weeks at any time during treatment, or SD that was maintained for at least 8 weeks after the start of treatment. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Outcome measures
| Measure |
G+E Standard Dose: Rash Grade < 2
n=75 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=70 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
|---|---|---|---|
|
Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST
|
62.7 percentage of participants
Interval 50.7 to 73.6
|
47.1 percentage of participants
Interval 35.1 to 59.4
|
—
|
SECONDARY outcome
Timeframe: BL and weekly thereafter for up to 46 months.Population: FAS
OS assessed from the start of the 4-week run in period was defined as the time from BL to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.
Outcome measures
| Measure |
G+E Standard Dose: Rash Grade < 2
n=106 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=75 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=70 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
|---|---|---|---|
|
Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In
|
84.9 percentage of participants
|
81.3 percentage of participants
|
85.7 percentage of participants
|
SECONDARY outcome
Timeframe: BL and weekly thereafter for up to 46 months.Population: FAS
OS assessed from the start of the 4-week run in period was defined as the median time, in months, from BL to the date of death, due to any cause. Participants who were still alive at the time of analysis were censored at the date they were last known to be alive. The 95% CI was determined using Kaplan-Meier methodology.
Outcome measures
| Measure |
G+E Standard Dose: Rash Grade < 2
n=106 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=75 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=70 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
|---|---|---|---|
|
OS Assessed From Start of 4-Week Run-In
|
7.9 months
Interval 7.1 to 8.8
|
9.3 months
Interval 7.3 to 10.9
|
8.0 months
Interval 6.8 to 9.2
|
SECONDARY outcome
Timeframe: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.Population: FAS
PFS as assessed from the start of 4-week run-in was defined as the time from BL to the first occurrence of PD according to RECIST or death due to any cause. For TLs, PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.
Outcome measures
| Measure |
G+E Standard Dose: Rash Grade < 2
n=106 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=75 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=70 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
|---|---|---|---|
|
Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In
|
90.6 percentage of participants
|
90.7 percentage of participants
|
88.6 percentage of participants
|
SECONDARY outcome
Timeframe: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.Population: FAS; only participants with an event of PD or death were included in the analysis.
PFS assessed from the start of 4-week run-in was defined as the median time, in weeks, from BL to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.
Outcome measures
| Measure |
G+E Standard Dose: Rash Grade < 2
n=96 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=68 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=62 Participants
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
|---|---|---|---|
|
PFS Assessed From the Start of 4-Week Run-In
|
17.1 weeks
Interval 16.0 to 22.7
|
23.4 weeks
Interval 20.0 to 31.0
|
19.3 weeks
Interval 15.3 to 23.1
|
Adverse Events
G+E: Rash ≥ Grade 2
Serious events: 39 serious events
Other events: 105 other events
Deaths: 0 deaths
G+E Standard Dose: Rash Grade < 2
Serious events: 24 serious events
Other events: 74 other events
Deaths: 0 deaths
G+E Escalating Dose: Rash Grade < 2
Serious events: 20 serious events
Other events: 71 other events
Deaths: 0 deaths
G+E: No Rash Non-Eligible
Serious events: 64 serious events
Other events: 178 other events
Deaths: 0 deaths
G+E: Early Drop Out
Serious events: 22 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
G+E: Rash ≥ Grade 2
n=105 participants at risk
Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Standard Dose: Rash Grade < 2
n=77 participants at risk
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=71 participants at risk
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E: No Rash Non-Eligible
n=178 participants at risk
Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E: Early Drop Out
n=36 participants at risk
Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Clostridial infection
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
3/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.2%
4/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
2/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.2%
4/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
5/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
5/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Enteritis
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Skin oedema
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Investigations
Blood glucose increased
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraganglion neoplasm
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
2/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Cardiac disorders
Angina pectoris
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Cardiac disorders
Cardiac arrest
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Cardiac disorders
Myocardial infarction
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Pneumonia
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.6%
2/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
3.4%
6/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Infection
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.2%
4/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Sepsis
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.7%
3/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Biliary sepsis
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Bronchopneumonia
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Device related infection
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Escherichia sepsis
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Klebsiella infection
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Orchitis
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Pyelonephritis acute
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Skin infection
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Superinfection
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Viral infection
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Vulvitis
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
4/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
2/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
3.4%
6/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
2/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Pyrexia
|
2.9%
3/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.6%
2/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
4.2%
3/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.1%
9/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
2/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
General physical health deterioration
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Chills
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Death
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Device occlusion
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Fatigue
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Malaise
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Oedema
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Pain
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Sudden death
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Hepatobiliary disorders
Cholangitis
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
2/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.7%
3/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
2/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
2/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Vascular disorders
Axillary vein thrombosis
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Vascular disorders
Embolism venous
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Vascular disorders
Hypertension
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.56%
1/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
Other adverse events
| Measure |
G+E: Rash ≥ Grade 2
n=105 participants at risk
Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Standard Dose: Rash Grade < 2
n=77 participants at risk
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E Escalating Dose: Rash Grade < 2
n=71 participants at risk
Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E: No Rash Non-Eligible
n=178 participants at risk
Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
|
G+E: Early Drop Out
n=36 participants at risk
Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.8%
26/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
33.8%
26/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
38.0%
27/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
37.1%
66/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
27.8%
10/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
38.1%
40/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
26.0%
20/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
23.9%
17/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
42.1%
75/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
8.3%
3/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Diarrhoea
|
46.7%
49/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
42.9%
33/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
49.3%
35/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
39.9%
71/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
25.0%
9/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Nausea
|
47.6%
50/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
36.4%
28/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
33.8%
24/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
38.8%
69/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
25.0%
9/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Vomiting
|
25.7%
27/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
22.1%
17/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
32.4%
23/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
24.2%
43/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
22.2%
8/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Abdominal pain
|
24.8%
26/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
16.9%
13/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
22.5%
16/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
27.5%
49/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
8.3%
3/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Constipation
|
21.9%
23/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
14.3%
11/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
21.1%
15/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
19.7%
35/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
11.1%
4/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.5%
10/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
7.8%
6/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
7.0%
5/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
11.2%
20/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
8.3%
3/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Ascites
|
2.9%
3/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
3.9%
3/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
2/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
4.5%
8/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
8.3%
3/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
44.8%
47/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
23.4%
18/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
21.1%
15/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
43.8%
78/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
22.2%
8/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.6%
8/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
9.1%
7/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
4.2%
3/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
16.3%
29/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
105/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
77.9%
60/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
90.1%
64/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
69.1%
123/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
52.8%
19/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.5%
10/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
9.1%
7/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
14.1%
10/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
12.9%
23/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.6%
9/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.2%
4/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
18.3%
13/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
9.0%
16/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Fatigue
|
30.5%
32/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
22.1%
17/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
32.4%
23/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
29.8%
53/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
8.3%
3/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Pyrexia
|
27.6%
29/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
28.6%
22/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
21.1%
15/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
24.7%
44/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
16.7%
6/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Asthenia
|
9.5%
10/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
13.0%
10/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
16.9%
12/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
16.3%
29/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
16.7%
6/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Oedema peripheral
|
14.3%
15/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
16.9%
13/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
8.5%
6/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
16.3%
29/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Mucosal inflammation
|
9.5%
10/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
10.4%
8/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
11.3%
8/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
8.4%
15/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
2/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.5%
31/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
22.1%
17/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
33.8%
24/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
29.2%
52/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
13.9%
5/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.8%
4/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.2%
4/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
12.7%
9/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
10/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
2/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
14/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
9.1%
7/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
9.9%
7/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
11.2%
20/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
15/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
9.1%
7/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
4.2%
3/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
9.6%
17/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
8.3%
3/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Investigations
Weight decreased
|
8.6%
9/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
9.1%
7/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
21.1%
15/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
12.4%
22/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
4/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
7.8%
6/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
7.0%
5/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
3.9%
7/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
11.1%
4/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Psychiatric disorders
Insomnia
|
12.4%
13/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
10.4%
8/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
11.3%
8/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
7.9%
14/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.6%
9/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
9.1%
7/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
14.1%
10/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.1%
9/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Headache
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
10.4%
8/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
4/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
3.4%
6/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.6%
8/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.6%
2/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
7.0%
5/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
6.7%
12/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.95%
1/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
4/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.7%
3/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Stomatitis
|
9.5%
10/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
6.5%
5/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
9.9%
7/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
4.5%
8/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
2/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.5%
10/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
3.9%
3/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
4.2%
3/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.1%
9/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
4/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
7.0%
5/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
6.7%
12/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
5/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.2%
4/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
2/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.1%
9/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
8.3%
3/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.9%
3/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
6.5%
5/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
7.0%
5/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
3.9%
7/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.2%
4/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
4.2%
3/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
5/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
2/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.6%
2/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
6.2%
11/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Psychiatric disorders
Depression
|
4.8%
5/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.2%
4/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
2/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
6.7%
12/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Psychiatric disorders
Anxiety
|
2.9%
3/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.2%
4/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
5/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
3.4%
6/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
8.3%
3/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Vascular disorders
Deep vein thrombosis
|
2.9%
3/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.2%
4/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
4.2%
3/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.7%
3/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
2/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Vascular disorders
Hypertension
|
4.8%
5/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
6.5%
5/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
4.2%
3/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
5/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
General physical health deterioration
|
3.8%
4/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.6%
2/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
4/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.1%
2/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Influenza like illness
|
6.7%
7/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.6%
2/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
2/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
5/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
General disorders
Pain
|
1.9%
2/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.2%
4/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
4/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.7%
3/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
3/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.6%
2/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
4/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
3.9%
7/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.3%
1/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
4.2%
3/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.6%
2/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Dizziness
|
4.8%
5/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.6%
2/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
7.0%
5/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
6.7%
12/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.8%
1/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Nervous system disorders
Dysgeusia
|
5.7%
6/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
5.2%
4/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
9.9%
7/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
3.9%
7/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
|
Infections and infestations
Urinary tract infection
|
7.6%
8/105 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
2.6%
2/77 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
1.4%
1/71 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
7.3%
13/178 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
0.00%
0/36 • Adverse events (AEs) were collected up to 28 days after discontinuation of study drug, drug-related serious AEs (SAEs) continued to be collected thereafter.
All participants who received at least 1 dose of trial medication and had at least 1 safety follow-up were included in the safety analysis population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER