Trial Outcomes & Findings for A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer. (NCT NCT00531960)
NCT ID: NCT00531960
Last Updated: 2014-11-11
Results Overview
Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause. Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0. For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Results posted on
2014-11-11
Participant Flow
Participant milestones
| Measure |
Bevacizumab Plus (+) Chemotherapy
Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 milligrams per square meter \[mg/m\^2\], IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m\^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m\^2, IV, followed by carboplatin 6 milligrams per milliliter multiplied by minute \[mg/mL\*min\] on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
|
Bevacizumab + Erlotinib
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
63
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
61
|
63
|
Reasons for withdrawal
| Measure |
Bevacizumab Plus (+) Chemotherapy
Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 milligrams per square meter \[mg/m\^2\], IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m\^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m\^2, IV, followed by carboplatin 6 milligrams per milliliter multiplied by minute \[mg/mL\*min\] on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
|
Bevacizumab + Erlotinib
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
42
|
41
|
|
Overall Study
Violation of Selection Criteria
|
2
|
0
|
|
Overall Study
Refused Treatment
|
5
|
6
|
|
Overall Study
Other
|
4
|
10
|
Baseline Characteristics
A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.
Baseline characteristics by cohort
| Measure |
Bevacizumab + Chemotherapy
n=61 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m\^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m\^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m\^2, IV, followed by carboplatin 6 mg/mL\*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
|
Bevacizumab + Erlotinib
n=63 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 9.55 • n=93 Participants
|
61.0 years
STANDARD_DEVIATION 10.94 • n=4 Participants
|
59.53 years
STANDARD_DEVIATION 10.34 • n=27 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.Population: FAS
Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause. Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0. For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization.
Outcome measures
| Measure |
Bevacizumab + Chemotherapy
n=61 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m\^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m\^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m\^2, IV, followed by carboplatin 6 mg/mL\*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
|
Bevacizumab + Erlotinib
n=63 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
|
|---|---|---|
|
Percentage of Participants With Disease Progression or Death
|
72.1 percentage of participants
|
76.2 percentage of participants
|
PRIMARY outcome
Timeframe: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.Population: FAS; only participants with an event (disease progression or death) were included in the analysis.
The median time, in weeks, from randomization to PFS event. Participants were censored at the date of last post-BL tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization. PFS was estimated using Kaplan-Meier methodology.
Outcome measures
| Measure |
Bevacizumab + Chemotherapy
n=44 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m\^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m\^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m\^2, IV, followed by carboplatin 6 mg/mL\*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
|
Bevacizumab + Erlotinib
n=48 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
|
|---|---|---|
|
PFS
|
34.6 weeks
Interval 25.0 to 42.4
|
23.4 weeks
Interval 17.4 to 45.1
|
SECONDARY outcome
Timeframe: Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.Population: FAS
Overall survival (OS) was defined as the time from randomization to the date of death, due to any cause. Participants were censored at final analysis at the date the participant was last known to be alive.
Outcome measures
| Measure |
Bevacizumab + Chemotherapy
n=61 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m\^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m\^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m\^2, IV, followed by carboplatin 6 mg/mL\*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
|
Bevacizumab + Erlotinib
n=63 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
|
|---|---|---|
|
Percentage of Participants Who Died
|
45.9 percentage of participants
|
52.4 percentage of participants
|
SECONDARY outcome
Timeframe: Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.Population: FAS; only participants who died were included in this analysis.
The median time, in months, from randomization to OS event. Participants were censored at final analysis at the date the participant was last known to be alive.
Outcome measures
| Measure |
Bevacizumab + Chemotherapy
n=28 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m\^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m\^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m\^2, IV, followed by carboplatin 6 mg/mL\*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
|
Bevacizumab + Erlotinib
n=33 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
|
|---|---|---|
|
OS
|
NA months
Interval 12.7 to
The median and upper limit of the 95% confidence interval (CI) could not be calculated due to the large number of censored events.
|
16.4 months
Interval 11.0 to
The upper limit of the 95% CI could not be calculated due to the large number of censored events.
|
SECONDARY outcome
Timeframe: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.Population: FAS
BOR was defined as the best response recorded from randomization until disease progression/recurrence or death, taking as reference for PD the smallest measurement (nadir) recorded since treatment started. Assignment of PR of CR required confirmation of tumor measurement changes by repeat assessments performed no less than 4 weeks after criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs; and PR was defined as at least a 30% decrease in the SLD of the TLs, taking BL SLD as reference. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was calculated using the Pearson-Clopper method.
Outcome measures
| Measure |
Bevacizumab + Chemotherapy
n=61 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m\^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m\^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m\^2, IV, followed by carboplatin 6 mg/mL\*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
|
Bevacizumab + Erlotinib
n=63 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
|
|---|---|---|
|
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
|
44.3 percentage of participants
Interval 31.5 to 57.6
|
27.0 percentage of participants
Interval 16.6 to 39.7
|
SECONDARY outcome
Timeframe: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visitPopulation: FAS
Disease control was defined as a BOR of CR, PR, or SD according to RECIST V 1.0 for at least 4 weeks at any time during randomized treatment or disease stabilization, after study entry. Participants without a post-BL assessment of response were considered as having no disease control. The 95% CI for the one sample binomial was calculated using the Pearson-Clopper method.
Outcome measures
| Measure |
Bevacizumab + Chemotherapy
n=61 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m\^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m\^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m\^2, IV, followed by carboplatin 6 mg/mL\*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
|
Bevacizumab + Erlotinib
n=63 Participants
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
|
|---|---|---|
|
Percentage of Participants With Disease Control According to RECIST V 1.0
|
85.2 percentage of participants
Interval 73.8 to 93.0
|
73.0 percentage of participants
Interval 60.3 to 83.4
|
Adverse Events
Bevacizumab + Chemotherapy
Serious events: 22 serious events
Other events: 58 other events
Deaths: 0 deaths
Bevacizumab + Erlotinib
Serious events: 17 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + Chemotherapy
n=60 participants at risk
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m\^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m\^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m\^2, IV, followed by carboplatin 6 mg/mL\*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
|
Bevacizumab + Erlotinib
n=63 participants at risk
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
5.0%
3/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Bronchitis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Gastroenteritis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Septic shock
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.0%
3/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Haematoma
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Peripheral embolism
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Spinal cord compression
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Death
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Weight decreased
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Psychiatric disorders
Confusional state
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Catheter site infection
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Viral infection
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
Other adverse events
| Measure |
Bevacizumab + Chemotherapy
n=60 participants at risk
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m\^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m\^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m\^2, IV, followed by carboplatin 6 mg/mL\*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
|
Bevacizumab + Erlotinib
n=63 participants at risk
Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
61.7%
37/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
19.0%
12/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
15/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
42.9%
27/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Vomiting
|
38.3%
23/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
7.9%
5/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
12/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
11.1%
7/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Stomatitis
|
13.3%
8/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
14.3%
9/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
4/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
11.1%
7/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
6/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
11.1%
7/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
6/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
6.3%
4/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
9/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
61.9%
39/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.3%
23/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
19.0%
12/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
3/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
23.8%
15/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
12.7%
8/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
10/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
30.2%
19/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.7%
7/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
17.5%
11/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
36.7%
22/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
14.3%
9/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.7%
4/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
7.9%
5/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.0%
3/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
11.1%
7/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
4/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
12.7%
8/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
24/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Anaemia
|
30.0%
18/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
26.7%
16/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
28.3%
17/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Asthenia
|
21.7%
13/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
11.1%
7/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Fatigue
|
31.7%
19/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
22.2%
14/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Mucosal inflammation
|
6.7%
4/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
7.9%
5/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Hypertension
|
23.3%
14/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
30.2%
19/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Headache
|
11.7%
7/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
19.0%
12/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
10/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Paronychia
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
12.7%
8/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
5/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
12.7%
8/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
9/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
7.9%
5/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
6/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Psychiatric disorders
Insomnia
|
11.7%
7/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
12.7%
8/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Renal and urinary disorders
Proteinuria
|
15.0%
9/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
19.0%
12/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Gingival bleeding
|
8.3%
5/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
4.8%
3/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Toothache
|
8.3%
5/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
7.9%
5/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
4.8%
3/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Periodontitis
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
4.8%
3/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Gastritis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Anal fistula
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Eructation
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Flatulence
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Gingival pain
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Gastrointestinal disorders
Oral pruritus
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
6.3%
4/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
6.3%
4/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
5.0%
3/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Chest pain
|
10.0%
6/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
9.5%
6/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Chest discomfort
|
6.7%
4/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
7.9%
5/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Pyrexia
|
5.0%
3/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
9.5%
6/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Pain
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
6.3%
4/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Oedema
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Oedema peripheral
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Chills
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Influenza like illness
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Axillary pain
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Discomfort
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Feeling cold
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Hunger
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Malaise
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
General disorders
Xerosis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Renal and urinary disorders
Haematuria
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Renal and urinary disorders
Dysuria
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Renal and urinary disorders
Pollakiuria
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
4/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Ear and labyrinth disorders
Vertigo
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
4/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
4.8%
3/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.0%
3/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.0%
3/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord atrophy
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Immune system disorders
Hypersensitivity
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Surgical and medical procedures
Tooth extraction
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Reproductive system and breast disorders
Vaginal ulceration
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Cardiac disorders
Palpitations
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Cardiac disorders
Atrioventricular block
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Cardiac disorders
Cardiovascular disorder
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Eye disorders
Vision blurred
|
5.0%
3/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Eye disorders
Blepharitis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Eye disorders
Diplopia
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Eye disorders
Eye pain
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Eye disorders
Cataract
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Eye disorders
Dry eye
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Eye disorders
Glaucoma
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
38.3%
23/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
17.5%
11/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.3%
5/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Dizziness
|
6.7%
4/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
6.3%
4/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Paraesthesia
|
8.3%
5/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
5/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Dysgeusia
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Hypoaesthesia
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Sciatica
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Syncope
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Hyperaesthesia
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Lethargy
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Migraine
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Presyncope
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Somnolence
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Tremor
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Nervous system disorders
Vascular dementia
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
5/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
9.5%
6/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
4/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
6.3%
4/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
4.8%
3/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
4.8%
3/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Catheter site infection
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Oral herpes
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Rhinitis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Skin infection
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Cystitis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Eye infection
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Fungal skin infection
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Influenza
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Localised infection
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Lung infection
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Nail infection
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Onychomycosis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Tinea pedis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Tooth abscess
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Tooth infection
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Phlebitis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Aortic thrombosis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Flushing
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Haemorrhage
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Hypotension
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Subclavian vein thrombosis
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Vascular disorders
Varicose vein
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
5/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
4.8%
3/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
5/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
4.8%
3/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
4.8%
3/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
3.2%
2/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Weight decreased
|
6.7%
4/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
4.8%
3/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
6.3%
4/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
4.8%
3/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Blood creatinine increased
|
5.0%
3/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Blood potassium decreased
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Blood urea increased
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Weight increased
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Blood uric acid increased
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Electrocardiogram T wave inversion
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Lymphocyte count increased
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Monocyte count increased
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
Platelet count decreased
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Investigations
White blood cell count decreased
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Psychiatric disorders
Anxiety
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
4.8%
3/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Psychiatric disorders
Depression
|
3.3%
2/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Psychiatric disorders
Confusional state
|
1.7%
1/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
0.00%
0/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/60 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population.
|
1.6%
1/63 • Adverse events (AEs) and serious AEs (SAEs) were reported from Screening through Day 84. Unrelated events were reported up to 28 days after last study drug treatment, related events were reported until resolution or stabilization
All participants who received at least 1 dose of the study treatment and had at least 1 safety follow-up, whether withdrawn prematurely or not, 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