Trial Outcomes & Findings for Study of Pembrolizumab With or Without CC-486 in Patients With Platinum-resistant Ovarian Cancer (NCT NCT02900560)
NCT ID: NCT02900560
Last Updated: 2022-06-10
Results Overview
Safety evaluation: number of subjects with grade 3, 4, or 5 adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. This is an assessment of the frequency, severity and relationship to trial treatment of all adverse events that occurred while on trial. CTCAE is a standard classification and severity grading scale (from 1- mild to 5 - death) for adverse events in clinical trials and oncology settings.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
The average time period for patient participation was 30 weeks.
Results posted on
2022-06-10
Participant Flow
Participant milestones
| Measure |
Cohort 1
CC-486 100 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 2
CC-486 100 mg twice a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 3
CC-486 300 mg once a day, 14 days on and 14 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 4
CC-486 300 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
10
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Pembrolizumab With or Without CC-486 in Patients With Platinum-resistant Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1
n=9 Participants
CC-486 100 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 2
n=10 Participants
CC-486 100 mg twice a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 3
n=7 Participants
CC-486 300 mg once a day, 14 days on and 14 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 4
n=8 Participants
CC-486 300 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 8.89 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 13.15 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 12.47 • n=5 Participants
|
68.0 years
STANDARD_DEVIATION 6.39 • n=4 Participants
|
62.2 years
STANDARD_DEVIATION 11.20 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Primary Tumor Location
Epithelial Ovarian Cancer
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Primary Tumor Location
Fallopian Tube Carcinoma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Primary Tumor Location
Primary Peritoneal Carcinoma
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: The average time period for patient participation was 30 weeks.Population: Analysis is completed using the Safety Population as opposed to the "Intent-to-Treat" Population (all patients who were enrolled in the study, regardless of whether they actually received study medication). The Safety Population consists of all patients who receive any study treatment, and will be used for the analysis of safety data of the study.
Safety evaluation: number of subjects with grade 3, 4, or 5 adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. This is an assessment of the frequency, severity and relationship to trial treatment of all adverse events that occurred while on trial. CTCAE is a standard classification and severity grading scale (from 1- mild to 5 - death) for adverse events in clinical trials and oncology settings.
Outcome measures
| Measure |
Cohort 1
n=7 Participants
CC-486 100 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 2
n=10 Participants
CC-486 100 mg twice a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 3
n=7 Participants
CC-486 300 mg once a day, 14 days on and 14 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 4
n=8 Participants
CC-486 300 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
|---|---|---|---|---|
|
Number of Subjects With Grade 3, 4, or 5 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Patients with any Grade 3 or 4 Adverse Event
|
5 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Grade 3, 4, or 5 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Patients with Grade 5 Adverse Event
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3, 4, or 5 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Patients without Grade 3, 4, or 5 Adverse Event
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: The average time period for patient participation was 30 weeks.Population: Analysis was performed on the intent-to-treat (ITT) population (i.e., patients who were enrolled in the study, regardless of whether they actually received study medication), which is different from the safety population (i.e., patients who receive any study treatment) used for safety analysis.
Efficacy evaluation: based on the Immune-related Objective Response Rate (irORR)/ Immune-related Disease Control Rate (irDCR) per Immune-Related Response Evaluation Criteria In Solid Tumor (irRECIST) criteria using the intent-to-treat (ITT) population (all patients who were enrolled in the study, regardless of whether they actually received study medication). The best overall response outcome (irCR/irPR/irSD/irPD/irNE) will be summarized and tabulated for ITT by cohort.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
CC-486 100 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 2
n=10 Participants
CC-486 100 mg twice a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 3
n=7 Participants
CC-486 300 mg once a day, 14 days on and 14 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 4
n=8 Participants
CC-486 300 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
|---|---|---|---|---|
|
Number of Subjects With Immune-related Partial Response (irPR), Immune-related Complete Response (irCR), Immune-related Stable Disease (irSD), Immune-related Progressive Disease (irPD), and Immune-related Not Evaluable (irNE) as Assessed by irRECIST.
irPR
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Immune-related Partial Response (irPR), Immune-related Complete Response (irCR), Immune-related Stable Disease (irSD), Immune-related Progressive Disease (irPD), and Immune-related Not Evaluable (irNE) as Assessed by irRECIST.
irCR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Immune-related Partial Response (irPR), Immune-related Complete Response (irCR), Immune-related Stable Disease (irSD), Immune-related Progressive Disease (irPD), and Immune-related Not Evaluable (irNE) as Assessed by irRECIST.
irSD
|
3 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Immune-related Partial Response (irPR), Immune-related Complete Response (irCR), Immune-related Stable Disease (irSD), Immune-related Progressive Disease (irPD), and Immune-related Not Evaluable (irNE) as Assessed by irRECIST.
irPD
|
5 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Immune-related Partial Response (irPR), Immune-related Complete Response (irCR), Immune-related Stable Disease (irSD), Immune-related Progressive Disease (irPD), and Immune-related Not Evaluable (irNE) as Assessed by irRECIST.
irNE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Immune-related Partial Response (irPR), Immune-related Complete Response (irCR), Immune-related Stable Disease (irSD), Immune-related Progressive Disease (irPD), and Immune-related Not Evaluable (irNE) as Assessed by irRECIST.
Missing
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: The average time period for patient participation was 30 weeks.Population: Analysis is completed using the Safety Population as opposed to the "Intent-to-Treat" Population (all patients who were enrolled in the study, regardless of whether they actually received study medication). The Safety Population consists of all patients who receive any study treatment, and will be used for the analysis of safety data of the study.
Safety evaluation: number of subjects with treatment emergent adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. This is an assessment of the frequency and relationship to trial treatment of all adverse events that occurred while on trial. CTCAE is a standard classification and severity grading scale (from 1- mild to 5 - death) for adverse events in clinical trials and oncology settings.
Outcome measures
| Measure |
Cohort 1
n=7 Participants
CC-486 100 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 2
n=10 Participants
CC-486 100 mg twice a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 3
n=7 Participants
CC-486 300 mg once a day, 14 days on and 14 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 4
n=8 Participants
CC-486 300 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
|---|---|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events Related to CC-486 as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
|
7 Participants
|
10 Participants
|
7 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: The average time period for patient participation was 30 weeks.Population: Analysis is completed using the Safety Population as opposed to the "Intent-to-Treat" Population (all patients who were enrolled in the study, regardless of whether they actually received study medication). The Safety Population consists of all patients who receive any study treatment, and will be used for the analysis of safety data of the study.
Safety evaluation: number of subjects with treatment emergent adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. This is an assessment of the frequency and relationship to trial treatment of all adverse events that occurred while on trial. CTCAE is a standard classification and severity grading scale (from 1- mild to 5 - death) for adverse events in clinical trials and oncology settings.
Outcome measures
| Measure |
Cohort 1
n=7 Participants
CC-486 100 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 2
n=10 Participants
CC-486 100 mg twice a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 3
n=7 Participants
CC-486 300 mg once a day, 14 days on and 14 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 4
n=8 Participants
CC-486 300 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
|---|---|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events Related to Pembrolizumab as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
|
6 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
Adverse Events
Cohort 1
Serious events: 3 serious events
Other events: 7 other events
Deaths: 6 deaths
Cohort 2
Serious events: 6 serious events
Other events: 10 other events
Deaths: 4 deaths
Cohort 3
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Cohort 4
Serious events: 1 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Cohort 1
n=7 participants at risk
CC-486 100 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 2
n=10 participants at risk
CC-486 100 mg twice a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 3
n=7 participants at risk
CC-486 300 mg once a day, 14 days on and 14 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 4
n=8 participants at risk
CC-486 300 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
20.0%
2/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Cardiac disorders
Cardiac arrest
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Cerebral infarction
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Vascular disorders
Embolism
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Vascular disorders
Thrombosis
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
General disorders
Fatigue
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
Other adverse events
| Measure |
Cohort 1
n=7 participants at risk
CC-486 100 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 2
n=10 participants at risk
CC-486 100 mg twice a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 3
n=7 participants at risk
CC-486 300 mg once a day, 14 days on and 14 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
Cohort 4
n=8 participants at risk
CC-486 300 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days
CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
Pembrolizumab: Pembrolizumab 200 mg IV every 21 days
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
71.4%
5/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
60.0%
6/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
100.0%
7/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
100.0%
8/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
71.4%
5/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
70.0%
7/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
71.4%
5/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
87.5%
7/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
7/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
40.0%
4/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
71.4%
5/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
37.5%
3/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.9%
3/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
40.0%
4/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
57.1%
4/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
87.5%
7/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Abdominal Pain
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
30.0%
3/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Ascites
|
42.9%
3/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Abdominal Distension
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
20.0%
2/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
20.0%
2/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
42.9%
3/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
60.0%
6/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
57.1%
4/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
75.0%
6/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
42.9%
3/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Dehydration
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Increased appetite
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Malnutrition
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
General disorders
Fatigue
|
71.4%
5/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
30.0%
3/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
85.7%
6/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
87.5%
7/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
General disorders
Pyrexia
|
57.1%
4/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
General disorders
Odema Peripheral
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
General disorders
Chills
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
General disorders
Influenza like illness
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
General disorders
Asthenia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
General disorders
Catheter site pain
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
General disorders
Early satiety
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
General disorders
Oedema
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
General disorders
Pain
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Aspartate aminotransferase increased
|
57.1%
4/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
37.5%
3/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
62.5%
5/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Blood alkaline phosphatase increased
|
57.1%
4/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Lymphocyte count decreased
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
20.0%
2/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Weight decreased
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
37.5%
3/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Alanine aminotransferase increased
|
42.9%
3/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
37.5%
3/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Platelet count decreased
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
20.0%
2/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Blood creatinine decreased
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Neutrophil count increased
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Platelet count increased
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Protein total decreased
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Investigations
Weight increased
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
71.4%
5/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
30.0%
3/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
42.9%
3/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
57.1%
4/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
20.0%
2/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
30.0%
3/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Blood and lymphatic system disorders
Anaemia
|
42.9%
3/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
30.0%
3/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
42.9%
3/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
50.0%
4/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
20.0%
2/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
57.1%
4/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
37.5%
3/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
37.5%
3/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Headache
|
71.4%
5/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
85.7%
6/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
50.0%
4/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Neuropathy peripheral
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
42.9%
3/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Cerebral infarction
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Nervous system disorders
Taste disorder
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
2/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
20.0%
2/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Infections and infestations
Diverticulitis
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Infections and infestations
Labyrinthitis
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Infections and infestations
Systemic candida
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Psychiatric disorders
Insomnia
|
42.9%
3/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
20.0%
2/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
25.0%
2/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Psychiatric disorders
Libido decreased
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Vascular disorders
Hot flush
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Vascular disorders
Embolism
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Vascular disorders
Deep vein thrombosis
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Vascular disorders
Thrombosis
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Cardiac disorders
Cardiac arrest
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Cardiac disorders
Tachycardia
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Endocrine disorders
Hyperthyroidism
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Eye disorders
Visual impairment
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Eye disorders
Vitreous floaters
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Renal and urinary disorders
Acute kidney injury
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
12.5%
1/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
10.0%
1/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/10 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
14.3%
1/7 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
0.00%
0/8 • Adverse Event data were collected the from the time when the first patient consented (signed informed consent form) to the end of study for the last patient. The average timeframe for patient participation was 30 weeks for which data was collected/assessed.
The SAFETY population was used to assess clinical safety and tolerability and consisted of all subjects who were enrolled (Part A) and received at least one dose of study medication (this is different from the intent-to-treat population, which included all patients enrolled in the study, irrespective of treatment). All adverse experiences observed by the Investigator or reported by the patient were collected at each visit and any contact during the study and follow-up period.
|
Additional Information
Director, Project Management
Translational Research In Oncology (TRIO)
Phone: 33 158 10 09 09
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No publication, abstract or presentation of the study will be made without the approval of the Study Steering Committee (SSC).
- Publication restrictions are in place
Restriction type: OTHER