Trial Outcomes & Findings for Study to Evaluate Erlotinib With or Without SNDX-275 (Entinostat) in the Treatment of Patients With Advanced NSCLC (NCT NCT00602030)
NCT ID: NCT00602030
Last Updated: 2022-08-22
Results Overview
Safe recommended Phase 2 dose was determined based on dose-limiting toxicities (DLT) in Cycle 1. A DLT was defined as any of the following occurring in Cycle 1: Grade 3 or greater nonhematologic toxicity that was considered related to either entinostat or erlotinib or a Grade 4 hematologic toxicity lasting more than 7 days and/or resulting in a dose delay. Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scale was used where Grade 1=mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=life-threatening and 5=death. The dose that was found to be safe is reported.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
141 participants
Primary outcome timeframe
Cycle 1 of Lead-in Phase
Results posted on
2022-08-22
Participant Flow
Participants took part in the study at 23 investigative sites in the United States from 8 January 2008 to 1 February 2012.
Participants with a diagnosis of non-small cell lung carcinoma (NSCLC) were enrolled in 5 or 10 mg entinostat plus erlotinib arms to determine the Phase 2 dose. Participants were enrolled 1:1 in treatment arms: erlotinib 150 mg + entinostat 10 mg or erlotinib 150 mg + placebo. Placebo arm could receive entinostat 10 mg in the Crossover Phase.
Participant milestones
| Measure |
Lead-in Phase: Erlotinib + Entinostat 5 mg
Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
|
Lead-in Phase: Erlotinib + Entinostat 10 mg
Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
|
Double-blind Phase: Erlotinib + Placebo
Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
Crossover Phase: Erlotinib + Entinostat 10 mg
Participants in the Double-blind Phase Erlotinib + Placebo arm who experienced disease progression crossed over to receive open-label erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities.
|
|---|---|---|---|---|---|
|
Lead-in Phase
STARTED
|
3
|
6
|
0
|
0
|
0
|
|
Lead-in Phase
COMPLETED
|
1
|
1
|
0
|
0
|
0
|
|
Lead-in Phase
NOT COMPLETED
|
2
|
5
|
0
|
0
|
0
|
|
Double-blind Phase
STARTED
|
0
|
0
|
65
|
67
|
0
|
|
Double-blind Phase
Received Treatment
|
0
|
0
|
63
|
65
|
0
|
|
Double-blind Phase
COMPLETED
|
0
|
0
|
11
|
8
|
0
|
|
Double-blind Phase
NOT COMPLETED
|
0
|
0
|
54
|
59
|
0
|
|
Crossover Phase
STARTED
|
0
|
0
|
0
|
0
|
16
|
|
Crossover Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Crossover Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
16
|
Reasons for withdrawal
| Measure |
Lead-in Phase: Erlotinib + Entinostat 5 mg
Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
|
Lead-in Phase: Erlotinib + Entinostat 10 mg
Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
|
Double-blind Phase: Erlotinib + Placebo
Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
Crossover Phase: Erlotinib + Entinostat 10 mg
Participants in the Double-blind Phase Erlotinib + Placebo arm who experienced disease progression crossed over to receive open-label erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities.
|
|---|---|---|---|---|---|
|
Lead-in Phase
Disease Progression
|
2
|
3
|
0
|
0
|
0
|
|
Lead-in Phase
Adverse Event
|
0
|
2
|
0
|
0
|
0
|
|
Double-blind Phase
Disease progression
|
0
|
0
|
33
|
30
|
0
|
|
Double-blind Phase
Adverse Event
|
0
|
0
|
9
|
18
|
0
|
|
Double-blind Phase
Consent withdrawal
|
0
|
0
|
4
|
3
|
0
|
|
Double-blind Phase
Death
|
0
|
0
|
3
|
3
|
0
|
|
Double-blind Phase
Administrative decision
|
0
|
0
|
0
|
2
|
0
|
|
Double-blind Phase
Ineligibility
|
0
|
0
|
0
|
1
|
0
|
|
Double-blind Phase
Protocol deviation/noncompliance
|
0
|
0
|
1
|
0
|
0
|
|
Double-blind Phase
Reason not specified
|
0
|
0
|
4
|
2
|
0
|
|
Crossover Phase
Disease Progression
|
0
|
0
|
0
|
0
|
11
|
|
Crossover Phase
Adverse Event
|
0
|
0
|
0
|
0
|
3
|
|
Crossover Phase
Consent withdrawal
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Study to Evaluate Erlotinib With or Without SNDX-275 (Entinostat) in the Treatment of Patients With Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Lead-in Phase: Erlotinib + Entinostat 5 mg
n=3 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
|
Lead-in Phase: Erlotinib + Entinostat 10 mg
n=6 Participants
Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
|
Double-blind Phase: Erlotinib + Placebo
n=65 Participants
Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=67 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
63.5 years
n=7 Participants
|
67.0 years
n=5 Participants
|
66.0 years
n=4 Participants
|
67.1 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 of Lead-in PhasePopulation: Lead-in Safety Analysis Set included all participant who received at least one dose of study drug in the Lead-in Phase.
Safe recommended Phase 2 dose was determined based on dose-limiting toxicities (DLT) in Cycle 1. A DLT was defined as any of the following occurring in Cycle 1: Grade 3 or greater nonhematologic toxicity that was considered related to either entinostat or erlotinib or a Grade 4 hematologic toxicity lasting more than 7 days and/or resulting in a dose delay. Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scale was used where Grade 1=mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=life-threatening and 5=death. The dose that was found to be safe is reported.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=9 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
Identification of Safe-dose for the Phase 2 Double-blind Phase in the Lead-in Phase
|
10 milligrams (mg)
|
—
|
PRIMARY outcome
Timeframe: Month 4Population: Double-blind Per-protocol Analysis Set included all randomized participants who met key eligibility criteria, received an adequate course of treatment and who had baseline and postbaseline tumor measurements.
PFS rate at 4 months was defined as the percentage of participants who are progression-free at 4 months.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=50 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=53 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
4-Month Progression-free Survival (PFS) Rate in the Double-blind Phase
|
24.0 percentage of participants
Interval 12.2 to 35.8
|
20.8 percentage of participants
Interval 9.8 to 31.7
|
SECONDARY outcome
Timeframe: Month 6Population: Double-blind Full Analysis Set included all randomized participants.
ORR was defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) as assessed by the investigator. CR=disappearance of all target lesions; disappearance of non-target lesions and normalization of tumor marker level. PR=At least a 30% decrease in the sum of the longest diameter of target lesions, taking at reference the baseline sum longest diameter.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=65 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=67 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
Objective Response Rate (ORR) in the Double-blind Phase
|
9.2 percentage of participants
Interval 2.2 to 16.3
|
3.0 percentage of participants
Interval 0.0 to 7.1
|
SECONDARY outcome
Timeframe: Month 6Population: Full Analysis Set included all randomized participants.
PFS rate at 6 months is defined as the percentage of participants who are progression-free at 6 months.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=65 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=67 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
6-Month PFS Rate in the Double-blind Phase
|
10.8 percentage of participants
Interval 3.2 to 18.3
|
11.9 percentage of participants
Interval 4.2 to 19.7
|
SECONDARY outcome
Timeframe: First dose of study drug to within 30 days past last dose (Up to 7 months)Population: Safety Analysis Set included all participants who received at least one dose of study drug.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Worsening of a pre-existing medical condition was considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. A TEAE is an AE that starts after the administration of study drug. A SAE is any AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth effect or other significant medical hazard. TEAE severity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scale where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=Life-threatening and 5=Death.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=63 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=65 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) by Severity in the Double-blind Phase
Any SAE
|
29 Participants
|
32 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) by Severity in the Double-blind Phase
Any TEAE
|
63 Participants
|
65 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) by Severity in the Double-blind Phase
Grade 1 TEAE
|
7 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) by Severity in the Double-blind Phase
Grade 2 TEAE
|
16 Participants
|
12 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) by Severity in the Double-blind Phase
Grade 3 TEAE
|
20 Participants
|
34 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) by Severity in the Double-blind Phase
Grade 4 TEAE
|
5 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) by Severity in the Double-blind Phase
Grade 5 TEAE
|
15 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)Population: Safety Population included all participants who received at least one dose of study drug.
Laboratory tests included tests of Hematology and Chemistry. The individual laboratory values were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scale where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=Life-threatening and 5=Death.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=63 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=65 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Phosphorus decreased
|
4 Participants
|
6 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Creatinine abnormal
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Platelets decreased
|
1 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Sodium decreased
|
5 Participants
|
4 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Glucose increased
|
2 Participants
|
3 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Albumin decreased
|
4 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Potassium decreased
|
2 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Aspartate aminotransferase increased
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Bilirubin increased
|
3 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Magnesium decreased
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Potassium increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Calcium increased
|
2 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Calcium decreased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Alanine aminotransferase increased
|
1 Participants
|
6 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
White Blood Count decreased
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Absolute Neutrophil Count decreased
|
1 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Lymphocytes decreased
|
9 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)Population: Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=63 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=65 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
Vital Sign Values: Systolic Blood Pressure in the Double-blind Phase
Baseline
|
125.3 mm Hg
Standard Deviation 17.41
|
126.0 mm Hg
Standard Deviation 18.93
|
|
Vital Sign Values: Systolic Blood Pressure in the Double-blind Phase
Minimum Post-Baseline Value
|
112.4 mm Hg
Standard Deviation 13.95
|
105.0 mm Hg
Standard Deviation 15.14
|
|
Vital Sign Values: Systolic Blood Pressure in the Double-blind Phase
Maximum Post-Baseline Value
|
135.5 mm Hg
Standard Deviation 15.74
|
132.5 mm Hg
Standard Deviation 20.64
|
SECONDARY outcome
Timeframe: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)Population: Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=63 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=65 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
Vital Sign Values: Diastolic Blood Pressure in the Double-blind Phase
Baseline
|
72.5 mm Hg
Standard Deviation 10.06
|
72.1 mm Hg
Standard Deviation 10.38
|
|
Vital Sign Values: Diastolic Blood Pressure in the Double-blind Phase
Minimum Post-Baseline Value
|
64.7 mm Hg
Standard Deviation 9.31
|
61.3 mm Hg
Standard Deviation 9.70
|
|
Vital Sign Values: Diastolic Blood Pressure in the Double-blind Phase
Maximum Post-Baseline Value
|
78.8 mm Hg
Standard Deviation 9.92
|
78.5 mm Hg
Standard Deviation 10.09
|
SECONDARY outcome
Timeframe: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)Population: Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=63 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=65 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
Vital Sign Values: Heart Rate in the Double-blind Phase
Baseline
|
87.5 beats per minute (bpm)
Standard Deviation 15.96
|
85.6 beats per minute (bpm)
Standard Deviation 17.41
|
|
Vital Sign Values: Heart Rate in the Double-blind Phase
Minimum Post-Baseline Value
|
78.5 beats per minute (bpm)
Standard Deviation 16.75
|
79.7 beats per minute (bpm)
Standard Deviation 15.19
|
|
Vital Sign Values: Heart Rate in the Double-blind Phase
Maximum Post-Baseline Value
|
98.2 beats per minute (bpm)
Standard Deviation 15.24
|
102.1 beats per minute (bpm)
Standard Deviation 17.12
|
SECONDARY outcome
Timeframe: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)Population: Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=63 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=65 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
Vital Sign Values: Respiration Rate in the Double-blind Phase
Baseline
|
18.5 breaths per minute
Standard Deviation 2.56
|
17.9 breaths per minute
Standard Deviation 2.46
|
|
Vital Sign Values: Respiration Rate in the Double-blind Phase
Minimum Post-Baseline Value
|
17.2 breaths per minute
Standard Deviation 2.62
|
16.6 breaths per minute
Standard Deviation 2.34
|
|
Vital Sign Values: Respiration Rate in the Double-blind Phase
Maximum Post-Baseline Value
|
20.2 breaths per minute
Standard Deviation 3.14
|
20.1 breaths per minute
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)Population: Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=63 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=65 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
Vital Sign Values: Temperature in the Double-blind Phase
Baseline
|
97.5 degrees Celsius (C)
Standard Deviation 0.84
|
97.6 degrees Celsius (C)
Standard Deviation 0.90
|
|
Vital Sign Values: Temperature in the Double-blind Phase
Minimum Post-Baseline Value
|
96.9 degrees Celsius (C)
Standard Deviation 1.15
|
97.0 degrees Celsius (C)
Standard Deviation 0.91
|
|
Vital Sign Values: Temperature in the Double-blind Phase
Maximum Post-Baseline Value
|
98.2 degrees Celsius (C)
Standard Deviation 0.90
|
98.5 degrees Celsius (C)
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)Population: Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=63 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=65 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
Vital Sign Values: Weight in the Double-blind Phase
Baseline
|
77.9 kilograms (kg)
Standard Deviation 16.83
|
74.3 kilograms (kg)
Standard Deviation 17.48
|
|
Vital Sign Values: Weight in the Double-blind Phase
Minimum Post-Baseline Value
|
73.5 kilograms (kg)
Standard Deviation 16.98
|
70.0 kilograms (kg)
Standard Deviation 15.71
|
|
Vital Sign Values: Weight in the Double-blind Phase
Maximum Post-Baseline Value
|
77.6 kilograms (kg)
Standard Deviation 16.97
|
74.3 kilograms (kg)
Standard Deviation 16.93
|
SECONDARY outcome
Timeframe: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dosePopulation: Pharmacokinetic (PK) Population included all participants who had blood collected for PK parameters in the Lead-in Phase. Number analyzed is the number of participants with data available at the give timepoint.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=3 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=6 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
Cmax: Maximum Plasma Concentration of Entinostat in the Lead-in Phase
Day 1 (entinostat alone)
|
19.6 ng/mL
Standard Deviation 20.6
|
123.1 ng/mL
Standard Deviation 136.4
|
|
Cmax: Maximum Plasma Concentration of Entinostat in the Lead-in Phase
Day 15 (entinostat + erlotinib)
|
30.2 ng/mL
Standard Deviation 41.0
|
99.4 ng/mL
Standard Deviation 132.5
|
SECONDARY outcome
Timeframe: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dosePopulation: PK Population included all participants who had PK samples collected in the Lead-in Phase. Number analyzed is the number of participants with data available at the give time point.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=3 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=6 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
Tmax: Time to Cmax of Entinostat in the Lead-in Phase
Day 1 (entinostat alone)
|
0.83 hour
Standard Deviation 0.29
|
0.50 hour
Standard Deviation 0.00
|
|
Tmax: Time to Cmax of Entinostat in the Lead-in Phase
Day 15 (entinostat + erlotinib)
|
1.0 hour
Standard Deviation 0.9
|
1.3 hour
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dosePopulation: PK Population included all participants who had PK samples collected in the Lead-in Phase. Number analyzed is the number of participants with data available at the given timepoint
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=3 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=6 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
AUC(0-24): Area Under the Concentration-time Curve From Time 0 to 24 Hours in the Lead-in Phase
Day 1 (entinostat alone)
|
46.5 ng*hr/mL
Standard Deviation 12.2
|
133.3 ng*hr/mL
Standard Deviation 84.8
|
|
AUC(0-24): Area Under the Concentration-time Curve From Time 0 to 24 Hours in the Lead-in Phase
Day 15 (entinostat + erlotinib)
|
51.7 ng*hr/mL
Standard Deviation 24.6
|
110.2 ng*hr/mL
Standard Deviation 92.3
|
SECONDARY outcome
Timeframe: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dosePopulation: PK Population included all participants who had PK samples collected during the Lead-in Phase. Number analyzed is the number of participants with data available at the given timepoint.
Outcome measures
| Measure |
Lead-in Phase: Erlotinib + Entinostat
n=3 Participants
Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=6 Participants
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
|---|---|---|
|
AUC(0-last): Area Under the Concentration-time Curve From Time 0 to Last Quantifiable Concentration in the Lead-in Phase
Day 1 (entinostat alone)
|
152.1 ng*hr/mL
Standard Deviation 26.3
|
325.8 ng*hr/mL
Standard Deviation 193.1
|
|
AUC(0-last): Area Under the Concentration-time Curve From Time 0 to Last Quantifiable Concentration in the Lead-in Phase
Day 15 (entinostat + erlotinib)
|
51.7 ng*hr/mL
Standard Deviation 24.6
|
106.4 ng*hr/mL
Standard Deviation 96.8
|
Adverse Events
Lead-in Phase: Erlotinib + Entinostat 5 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Lead-in Phase: Erlotinib + Entinostat 10 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Double-blind Phase: Erlotinib + Placebo
Serious events: 29 serious events
Other events: 63 other events
Deaths: 0 deaths
Double-blind Phase: Erlotinib + Entinostat 10 mg
Serious events: 32 serious events
Other events: 64 other events
Deaths: 0 deaths
Crossover Phase: Erlotinib + Entinostat 10 mg
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lead-in Phase: Erlotinib + Entinostat 5 mg
n=3 participants at risk
Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
|
Lead-in Phase: Erlotinib + Entinostat 10 mg
n=6 participants at risk
Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
|
Double-blind Phase: Erlotinib + Placebo
n=63 participants at risk
Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=65 participants at risk
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
Crossover Phase: Erlotinib + Entinostat 10 mg
n=16 participants at risk
Participants in the Double-blind Phase Erlotinib + Placebo arm who experienced disease progression crossed over to receive open-label erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities.
|
|---|---|---|---|---|---|
|
General disorders
Disease progression
|
66.7%
2/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
25.4%
16/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
10.8%
7/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Monoarthritis
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
General disorders
Pain in extremity
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.2%
2/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
4.6%
3/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.2%
2/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
4.6%
3/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anemia Group
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.1%
2/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.1%
2/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.1%
2/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.1%
2/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.1%
2/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardia disorder
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
General disorders
Death
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hernia obstructive
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypotension
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia Group
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.2%
2/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Superior vena caval occlusion
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Congestive cardiac failure
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Lead-in Phase: Erlotinib + Entinostat 5 mg
n=3 participants at risk
Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
|
Lead-in Phase: Erlotinib + Entinostat 10 mg
n=6 participants at risk
Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
|
Double-blind Phase: Erlotinib + Placebo
n=63 participants at risk
Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
Double-blind Phase: Erlotinib + Entinostat 10 mg
n=65 participants at risk
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
|
Crossover Phase: Erlotinib + Entinostat 10 mg
n=16 participants at risk
Participants in the Double-blind Phase Erlotinib + Placebo arm who experienced disease progression crossed over to receive open-label erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Neuropathy
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Investigations
Protein total decreased
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
100.0%
6/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
47.6%
30/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
56.9%
37/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
18.8%
3/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
100.0%
3/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
83.3%
5/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
50.8%
32/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
58.5%
38/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
31.2%
5/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
50.0%
3/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
25.4%
16/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
49.2%
32/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
25.0%
4/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
50.0%
3/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
55.6%
35/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
50.8%
33/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
11.1%
7/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.9%
11/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.5%
2/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
14.3%
9/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.3%
8/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
11.1%
7/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
17.5%
11/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
30.8%
20/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
25.0%
4/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.7%
8/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
27.7%
18/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
31.2%
5/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia group
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.2%
2/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
15.4%
10/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
11.1%
7/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.9%
11/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.5%
2/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.7%
8/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
30.8%
20/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
9.5%
6/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.1%
2/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anemia group
|
66.7%
2/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
11.1%
7/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
23.1%
15/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
18.8%
3/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
15.9%
10/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
40.0%
26/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.5%
2/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
9.5%
6/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
13.8%
9/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
18.8%
3/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.3%
4/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
7.7%
5/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.3%
4/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
4.6%
3/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
11.1%
7/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
9.2%
6/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
18.8%
3/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
7.9%
5/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.1%
2/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia group
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.2%
2/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
7.9%
5/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
9.5%
6/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
13.8%
9/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
9.5%
6/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
4.6%
3/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Eye disorders
Photophobia
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.2%
2/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.3%
8/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
General disorders
Xerosis
|
33.3%
1/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
17.5%
11/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
32.3%
21/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
18.8%
3/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
7.9%
5/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
15.4%
10/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
19.0%
12/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
15.4%
10/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
4.8%
3/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
13.8%
9/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
25.0%
4/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.3%
4/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.3%
8/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.3%
8/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.3%
8/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.5%
2/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.2%
2/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
7.7%
5/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
4.8%
3/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
7.7%
5/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.6%
1/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
7.7%
5/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
4.8%
3/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.5%
2/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.3%
4/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.3%
4/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
4.6%
3/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
7.9%
5/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
4.6%
3/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
7.9%
5/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.1%
2/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
9.5%
6/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
18.8%
3/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.5%
2/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.5%
2/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.5%
2/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
General disorders
Oedema
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
12.5%
2/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
4.8%
3/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Eye disorders
Eye discharge
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
3.2%
2/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
4.8%
3/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.2%
1/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/3 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
6.3%
4/63 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
18.8%
3/16 • First dose of study drug to 30 days past last dose (up to 7 months)
Number of participants at risk for Serious and Other Adverse events was based on the Safety Population that included all participants who received at least one dose of study drug.
|
Additional Information
Michael Meyers, MD, PhD, Chief Medical Officer
Syndax Pharmaceuticals, Inc.
Phone: +1-646-690-7620
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of the results of the multi-center Study shall not be made before the first multi-site publication by Sponsor or Publications Committee. No Public Presentation by Institution or Investigator will be made until Study Documentation/Results from all sites are received and analyzed by Sponsor. Separate publication by Investigator will be delayed for a period of 18 months until the initial publication by Committee or Sponsor, or a determination is made not to make such publication.
- Publication restrictions are in place
Restriction type: OTHER