Trial Outcomes & Findings for Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic Solid Tumors (NCT NCT02705105)
NCT ID: NCT02705105
Last Updated: 2024-04-25
Results Overview
The MTD was defined as one dose level below the dose level of the cohort where ≥ one-third of the subjects experienced a dose-limiting toxicity (DLT)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
114 participants
Primary outcome timeframe
From the first dose of study medications until 14 days after the last dose of study medication
Results posted on
2024-04-25
Participant Flow
Participant milestones
| Measure |
Phase 1
Dose-finding cohort to identify the maximum tolerated dose (MTD), or the highest protocol-defined dose in the absence of exceeding the MTD, for the combination regimen.
|
Phase 2
Expansion cohort, subjects were treated with the highest dose of the combination regimen that was considered tolerable in Phase 1.
|
|---|---|---|
|
Treatment
STARTED
|
4
|
110
|
|
Treatment
Subjects Who Were Replaced
|
1
|
0
|
|
Treatment
D/C From Treatment Phase
|
4
|
107
|
|
Treatment
D/C From Follow-Up
|
4
|
110
|
|
Treatment
COMPLETED
|
0
|
1
|
|
Treatment
NOT COMPLETED
|
4
|
109
|
|
Follow-Up
STARTED
|
4
|
110
|
|
Follow-Up
COMPLETED
|
0
|
0
|
|
Follow-Up
NOT COMPLETED
|
4
|
110
|
Reasons for withdrawal
| Measure |
Phase 1
Dose-finding cohort to identify the maximum tolerated dose (MTD), or the highest protocol-defined dose in the absence of exceeding the MTD, for the combination regimen.
|
Phase 2
Expansion cohort, subjects were treated with the highest dose of the combination regimen that was considered tolerable in Phase 1.
|
|---|---|---|
|
Treatment
Objective Disease Progression
|
1
|
50
|
|
Treatment
Withdrawal by Subject
|
3
|
5
|
|
Treatment
Adverse Event
|
0
|
17
|
|
Treatment
Clinical Disease Progression
|
0
|
32
|
|
Treatment
Physician Decision
|
0
|
3
|
|
Treatment
Ongoing w/ Treatment at time of data cut
|
0
|
2
|
|
Follow-Up
Death
|
3
|
68
|
|
Follow-Up
Withdrawal by Subject
|
1
|
14
|
|
Follow-Up
Study Terminated
|
0
|
26
|
|
Follow-Up
Discontinued per Amendment 3
|
0
|
2
|
Baseline Characteristics
Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
All in Phase 1 Cohort
n=4 Participants
All subjects in dose-finding cohort
|
NSCLC, Squamous Cell
n=5 Participants
Subjects in expansion cohort with squamous cell NSCLC
|
NSCLC, Nonsquamous, PD-L1 Non-Expressing
n=4 Participants
Subjects in expansion cohort with non-expressing, nonsquamous, PD-L1 NSCLC
|
Squamous Cell Carcinoma of Head and Neck
n=10 Participants
Subjects in expansion cohort with head \& neck squamous cell carcinoma
|
Colorectal Carcinoma, Non-MSI High
n=29 Participants
Subjects in expansion cohort with colorectal carcinoma
|
Ovarian/Fallopian Tube/Primary Peritoneal Carcinoma
n=21 Participants
Subjects in expansion cohort with ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma
|
Hepatocellular Carcinoma (HCC)
n=24 Participants
Subjects in expansion cohort with hepatocellular carcinoma
|
Pancreatic Adenocarcinoma
n=17 Participants
Subjects in expansion cohort with pancreatic adenocarcinoma
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
65 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
49 Participants
n=42 Participants
|
|
Age, Continuous
|
58.3 years
n=5 Participants
|
68.8 years
n=7 Participants
|
65.5 years
n=5 Participants
|
60.2 years
n=4 Participants
|
53.8 years
n=21 Participants
|
61.2 years
n=8 Participants
|
65.4 years
n=8 Participants
|
67.1 years
n=24 Participants
|
61.4 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
53 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
61 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
99 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
9 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
97 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
114 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study medications until 14 days after the last dose of study medicationThe MTD was defined as one dose level below the dose level of the cohort where ≥ one-third of the subjects experienced a dose-limiting toxicity (DLT)
Outcome measures
| Measure |
All in Phase 1 Cohort
n=4 Participants
All subjects in dose-finding cohort
|
NSCLC, Squamous Cell
Subjects in expansion cohort with squamous cell NSCLC
|
NSCLC, Nonsquamous, PD-L1 Non-expressing
Subjects in expansion cohort with non-expressing, nonsquamous, PD-L1 NSCLC
|
Squamous Cell Carcinoma of Head and Neck
Subjects in expansion cohort with head \& neck squamous cell carcinoma
|
Colorectal Carcinoma, Non-MSI Hign
Subjects in expansion cohort with colorectal carcinoma
|
Ovarian/Fallopian Tube/Primary Peritoneal Carcinoma
Subjects in expansion cohort with ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma
|
Hepatocellular Carcinoma
Subjects in expansion cohort with hepatocellular carcinoma
|
Pancreatic Adenocarcinoma
Subjects in expansion cohort with pancreatic adenocarcinoma
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
Subjects who successfully tolerated Dose Level 1
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Tolerated Dose (MTD)
Subjects enrolled at Dose Level 1
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study medications until 14 days after the last dose of study medicationcombination of mogamulizumab and nivolumab
Outcome measures
| Measure |
All in Phase 1 Cohort
n=4 Participants
All subjects in dose-finding cohort
|
NSCLC, Squamous Cell
Subjects in expansion cohort with squamous cell NSCLC
|
NSCLC, Nonsquamous, PD-L1 Non-expressing
Subjects in expansion cohort with non-expressing, nonsquamous, PD-L1 NSCLC
|
Squamous Cell Carcinoma of Head and Neck
Subjects in expansion cohort with head \& neck squamous cell carcinoma
|
Colorectal Carcinoma, Non-MSI Hign
Subjects in expansion cohort with colorectal carcinoma
|
Ovarian/Fallopian Tube/Primary Peritoneal Carcinoma
Subjects in expansion cohort with ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma
|
Hepatocellular Carcinoma
Subjects in expansion cohort with hepatocellular carcinoma
|
Pancreatic Adenocarcinoma
Subjects in expansion cohort with pancreatic adenocarcinoma
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Experiencing Dose-limiting Toxicity
Subjects enrolled at Dose Level 1
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Experiencing Dose-limiting Toxicity
Subjects who experienced DLT at Dose Level 1
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to every 12 weeks, until data cut offPopulation: Efficacy Analysis Set
To evaluate the anti-tumor activity of the combination of mogamulizumab and nivolumab based on the Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Outcome measures
| Measure |
All in Phase 1 Cohort
n=4 Participants
All subjects in dose-finding cohort
|
NSCLC, Squamous Cell
n=5 Participants
Subjects in expansion cohort with squamous cell NSCLC
|
NSCLC, Nonsquamous, PD-L1 Non-expressing
n=4 Participants
Subjects in expansion cohort with non-expressing, nonsquamous, PD-L1 NSCLC
|
Squamous Cell Carcinoma of Head and Neck
n=10 Participants
Subjects in expansion cohort with head \& neck squamous cell carcinoma
|
Colorectal Carcinoma, Non-MSI Hign
n=29 Participants
Subjects in expansion cohort with colorectal carcinoma
|
Ovarian/Fallopian Tube/Primary Peritoneal Carcinoma
n=21 Participants
Subjects in expansion cohort with ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma
|
Hepatocellular Carcinoma
n=24 Participants
Subjects in expansion cohort with hepatocellular carcinoma
|
Pancreatic Adenocarcinoma
n=17 Participants
Subjects in expansion cohort with pancreatic adenocarcinoma
|
|---|---|---|---|---|---|---|---|---|
|
Objective Tumor Response Rate According to RECIST
|
25 percentage of participants
Interval 0.6 to 80.6
|
20 percentage of participants
Interval 0.5 to 71.6
|
25 percentage of participants
Interval 0.6 to 80.6
|
10 percentage of participants
Interval 0.3 to 44.5
|
3.4 percentage of participants
Interval 0.1 to 17.8
|
14.3 percentage of participants
Interval 3.0 to 36.3
|
16.7 percentage of participants
Interval 4.7 to 37.4
|
0 percentage of participants
Interval 0.0 to 19.5
|
Adverse Events
All in Phase 1 Cohort
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
NSCLC, Squamous Cell
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
NSCLC, Nonsquamous, PD-L1 Non-Expressing
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Squamous Cell Carcinoma of Head and Neck
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Colorectal Carcinoma, Non-MSI High
Serious events: 18 serious events
Other events: 28 other events
Deaths: 1 deaths
Ovarian/Fallopian Tube/Primary Peritoneal Carcinoma
Serious events: 11 serious events
Other events: 21 other events
Deaths: 0 deaths
Hepatocellular Carcinoma (HCC)
Serious events: 17 serious events
Other events: 24 other events
Deaths: 2 deaths
Pancreatic Adenocarcinoma
Serious events: 11 serious events
Other events: 17 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
All in Phase 1 Cohort
n=4 participants at risk
All subjects in dose-finding cohort
|
NSCLC, Squamous Cell
n=5 participants at risk
Subjects in expansion cohort with squamous cell NSCLC
|
NSCLC, Nonsquamous, PD-L1 Non-Expressing
n=4 participants at risk
Subjects in expansion cohort with non-expressing, nonsquamous, PD-L1 NSCLC
|
Squamous Cell Carcinoma of Head and Neck
n=10 participants at risk
Subjects in expansion cohort with head \& neck squamous cell carcinoma
|
Colorectal Carcinoma, Non-MSI High
n=29 participants at risk
Subjects in expansion cohort with colorectal carcinoma
|
Ovarian/Fallopian Tube/Primary Peritoneal Carcinoma
n=21 participants at risk
Subjects in expansion cohort with ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma
|
Hepatocellular Carcinoma (HCC)
n=24 participants at risk
Subjects in expansion cohort with hepatocellular carcinoma
|
Pancreatic Adenocarcinoma
n=17 participants at risk
Subjects in expansion cohort with pancreatic adenocarcinoma
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.3%
3/29 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
12.5%
3/24 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
13.8%
4/29 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Asthenia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Chills
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Fatigue
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Multi-organ failure
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Nuclear magnetic resonance imaging brain abnormal
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Dactylitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
12.5%
3/24 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
25.0%
1/4 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
Other adverse events
| Measure |
All in Phase 1 Cohort
n=4 participants at risk
All subjects in dose-finding cohort
|
NSCLC, Squamous Cell
n=5 participants at risk
Subjects in expansion cohort with squamous cell NSCLC
|
NSCLC, Nonsquamous, PD-L1 Non-Expressing
n=4 participants at risk
Subjects in expansion cohort with non-expressing, nonsquamous, PD-L1 NSCLC
|
Squamous Cell Carcinoma of Head and Neck
n=10 participants at risk
Subjects in expansion cohort with head \& neck squamous cell carcinoma
|
Colorectal Carcinoma, Non-MSI High
n=29 participants at risk
Subjects in expansion cohort with colorectal carcinoma
|
Ovarian/Fallopian Tube/Primary Peritoneal Carcinoma
n=21 participants at risk
Subjects in expansion cohort with ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma
|
Hepatocellular Carcinoma (HCC)
n=24 participants at risk
Subjects in expansion cohort with hepatocellular carcinoma
|
Pancreatic Adenocarcinoma
n=17 participants at risk
Subjects in expansion cohort with pancreatic adenocarcinoma
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
60.0%
3/5 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
50.0%
5/10 • Number of events 9 • From the date of informed consent to 100 days after the last dose of IMP.
|
51.7%
15/29 • Number of events 23 • From the date of informed consent to 100 days after the last dose of IMP.
|
47.6%
10/21 • Number of events 14 • From the date of informed consent to 100 days after the last dose of IMP.
|
66.7%
16/24 • Number of events 24 • From the date of informed consent to 100 days after the last dose of IMP.
|
47.1%
8/17 • Number of events 12 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Hernia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Malaise
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
60.0%
3/5 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
4/10 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
24.1%
7/29 • Number of events 16 • From the date of informed consent to 100 days after the last dose of IMP.
|
19.0%
4/21 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
41.7%
10/24 • Number of events 18 • From the date of informed consent to 100 days after the last dose of IMP.
|
41.2%
7/17 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
6/24 • Number of events 9 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
2/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Cardiac disorders
Palpitations
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Cardiac disorders
Tachycardia
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.7%
6/29 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
30.0%
3/10 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.3%
3/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Eye disorders
Eye swelling
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
19.0%
4/21 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
38.1%
8/21 • Number of events 8 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.8%
5/24 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
31.0%
9/29 • Number of events 13 • From the date of informed consent to 100 days after the last dose of IMP.
|
33.3%
7/21 • Number of events 10 • From the date of informed consent to 100 days after the last dose of IMP.
|
37.5%
9/24 • Number of events 9 • From the date of informed consent to 100 days after the last dose of IMP.
|
29.4%
5/17 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
16.7%
4/24 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
50.0%
5/10 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.7%
6/29 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
38.1%
8/21 • Number of events 9 • From the date of informed consent to 100 days after the last dose of IMP.
|
12.5%
3/24 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
29.4%
5/17 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
3/4 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
2/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
30.0%
3/10 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
24.1%
7/29 • Number of events 8 • From the date of informed consent to 100 days after the last dose of IMP.
|
57.1%
12/21 • Number of events 21 • From the date of informed consent to 100 days after the last dose of IMP.
|
33.3%
8/24 • Number of events 20 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
14.3%
3/21 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
12.5%
3/24 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
2/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
4/10 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
27.6%
8/29 • Number of events 11 • From the date of informed consent to 100 days after the last dose of IMP.
|
42.9%
9/21 • Number of events 13 • From the date of informed consent to 100 days after the last dose of IMP.
|
45.8%
11/24 • Number of events 16 • From the date of informed consent to 100 days after the last dose of IMP.
|
35.3%
6/17 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Oedema mouth
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.3%
3/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
12.5%
3/24 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
4/10 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
37.9%
11/29 • Number of events 15 • From the date of informed consent to 100 days after the last dose of IMP.
|
28.6%
6/21 • Number of events 9 • From the date of informed consent to 100 days after the last dose of IMP.
|
41.7%
10/24 • Number of events 18 • From the date of informed consent to 100 days after the last dose of IMP.
|
29.4%
5/17 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Asthenia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Chest pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Chills
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Face oedema
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Facial pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
24.1%
7/29 • Number of events 8 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
6/24 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
29.4%
5/17 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
General disorders
Pyrexia
|
50.0%
2/4 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.7%
6/29 • Number of events 9 • From the date of informed consent to 100 days after the last dose of IMP.
|
23.8%
5/21 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
6/24 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Immune system disorders
Drug hypersensitivity
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
17.2%
5/29 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
12.5%
3/24 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.3%
3/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
14.3%
3/21 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
16.7%
4/24 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.3%
3/29 • Number of events 8 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
12.5%
3/24 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
16.7%
4/24 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
2/5 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
50.0%
5/10 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
48.3%
14/29 • Number of events 14 • From the date of informed consent to 100 days after the last dose of IMP.
|
33.3%
7/21 • Number of events 8 • From the date of informed consent to 100 days after the last dose of IMP.
|
29.2%
7/24 • Number of events 9 • From the date of informed consent to 100 days after the last dose of IMP.
|
29.4%
5/17 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Radiation associated pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
33.3%
7/21 • Number of events 19 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.8%
5/24 • Number of events 10 • From the date of informed consent to 100 days after the last dose of IMP.
|
17.6%
3/17 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 9 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
30.0%
3/10 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
33.3%
7/21 • Number of events 19 • From the date of informed consent to 100 days after the last dose of IMP.
|
29.2%
7/24 • Number of events 12 • From the date of informed consent to 100 days after the last dose of IMP.
|
23.5%
4/17 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
12.5%
3/24 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.3%
3/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
16.7%
4/24 • Number of events 13 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
16.7%
4/24 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Carbon dioxide increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Lipase decreased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
14.3%
3/21 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
12.5%
3/24 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Thyroxine free increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Tri-iodothyronine free increased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
Weight decreased
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
2/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
30.0%
3/10 • Number of events 8 • From the date of informed consent to 100 days after the last dose of IMP.
|
27.6%
8/29 • Number of events 10 • From the date of informed consent to 100 days after the last dose of IMP.
|
14.3%
3/21 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.8%
5/24 • Number of events 13 • From the date of informed consent to 100 days after the last dose of IMP.
|
17.6%
3/17 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
24.1%
7/29 • Number of events 8 • From the date of informed consent to 100 days after the last dose of IMP.
|
38.1%
8/21 • Number of events 10 • From the date of informed consent to 100 days after the last dose of IMP.
|
41.7%
10/24 • Number of events 13 • From the date of informed consent to 100 days after the last dose of IMP.
|
41.2%
7/17 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
24.1%
7/29 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
19.0%
4/21 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.8%
5/24 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
12.5%
3/24 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
16.7%
4/24 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
17.6%
3/17 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
17.6%
3/17 • Number of events 8 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
2/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
4/10 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
17.2%
5/29 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
33.3%
8/24 • Number of events 22 • From the date of informed consent to 100 days after the last dose of IMP.
|
23.5%
4/17 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
14.3%
3/21 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
16.7%
4/24 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
2/5 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
30.0%
3/10 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.3%
3/29 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.8%
5/24 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
17.6%
3/17 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
30.0%
3/10 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.3%
3/29 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
28.6%
6/21 • Number of events 13 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.8%
5/24 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
2/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
13.8%
4/29 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
19.0%
4/21 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
12.5%
3/24 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Dactylitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
16.7%
4/24 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
30.0%
3/10 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
19.0%
4/21 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
12.5%
3/24 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.3%
3/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
16.7%
4/24 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
6/24 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
2/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
27.6%
8/29 • Number of events 8 • From the date of informed consent to 100 days after the last dose of IMP.
|
33.3%
7/21 • Number of events 12 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.3%
3/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.3%
3/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
29.2%
7/24 • Number of events 8 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.7%
6/29 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
28.6%
6/21 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
12.5%
3/24 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
2/4 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
2/5 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
24.1%
7/29 • Number of events 8 • From the date of informed consent to 100 days after the last dose of IMP.
|
19.0%
4/21 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
45.8%
11/24 • Number of events 14 • From the date of informed consent to 100 days after the last dose of IMP.
|
17.6%
3/17 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
14.3%
3/21 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
2/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.3%
3/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
23.8%
5/21 • Number of events 6 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal disorder
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
40.0%
2/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
50.0%
2/4 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
60.0%
3/5 • Number of events 8 • From the date of informed consent to 100 days after the last dose of IMP.
|
75.0%
3/4 • Number of events 14 • From the date of informed consent to 100 days after the last dose of IMP.
|
50.0%
5/10 • Number of events 8 • From the date of informed consent to 100 days after the last dose of IMP.
|
51.7%
15/29 • Number of events 48 • From the date of informed consent to 100 days after the last dose of IMP.
|
66.7%
14/21 • Number of events 34 • From the date of informed consent to 100 days after the last dose of IMP.
|
58.3%
14/24 • Number of events 50 • From the date of informed consent to 100 days after the last dose of IMP.
|
35.3%
6/17 • Number of events 19 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
16.7%
4/24 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.2%
1/24 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
25.0%
1/4 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
6.9%
2/29 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
8.3%
2/24 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
11.8%
2/17 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
60.0%
3/5 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.3%
3/29 • Number of events 5 • From the date of informed consent to 100 days after the last dose of IMP.
|
9.5%
2/21 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Vascular disorders
Hypotension
|
50.0%
2/4 • Number of events 2 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.0%
1/5 • Number of events 3 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
4.8%
1/21 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
20.8%
5/24 • Number of events 7 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
3.4%
1/29 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/10 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
5.9%
1/17 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/5 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/4 • From the date of informed consent to 100 days after the last dose of IMP.
|
10.0%
1/10 • Number of events 1 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/29 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/21 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/24 • From the date of informed consent to 100 days after the last dose of IMP.
|
0.00%
0/17 • From the date of informed consent to 100 days after the last dose of IMP.
|
Additional Information
Kyowa Kirin Pharmaceutical Development
Kyowa Kirin Pharmaceutical Development
Phone: 609-919-1100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60