Trial Outcomes & Findings for An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread. (NCT NCT02598960)
NCT ID: NCT02598960
Last Updated: 2023-03-06
Results Overview
Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths. AEs and laboratory values will be graded according to the NCI CTCAE version 4.03.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
295 participants
Primary outcome timeframe
From first treatment to 100 days post last dose. Approximately 29 months
Results posted on
2023-03-06
Participant Flow
Participant milestones
| Measure |
Part A: BMS-986156 10mg
BMS-986156 10mg Q2W
|
Part A: BMS-986156 30mg
BMS-986156 30mg Q2W
|
Part A: BMS-986156 100mg
BMS-986156 100mg Q2W
|
Part A: BMS-986156 240mg
BMS-986156 240mg Q2W
|
Part A: BMS-986156 800mg
BMS-986156 800mg Q2W
|
Part C: BMS-986156 240mg
BMS-986156 240mg Q2W
|
Part C: BMS-986156 800mg
BMS-986156 800mg Q2W
|
Part B: BMS-986156 30mg + Nivo 240mg
BMS986156 30mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 100mg + Nivo 240mg
BMS986156 100mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 240mg + Nivo 240mg
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 800mg + Nivo 240mg
BMS986156 800mg Q2W + Nivo 240mg Q2W
|
Part D: BMS-986156 240mg + Nivo 240mg
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part E: BMS-986156 480mg + Nivo 480mg
BMS986156 480mg Q4W + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period
STARTED
|
4
|
6
|
4
|
6
|
9
|
3
|
2
|
3
|
9
|
14
|
11
|
188
|
33
|
|
Treatment Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
3
|
3
|
23
|
7
|
|
Treatment Period
NOT COMPLETED
|
4
|
6
|
4
|
6
|
9
|
2
|
2
|
3
|
7
|
11
|
8
|
165
|
26
|
|
Participants Entering Follow Up Period
STARTED
|
4
|
6
|
4
|
6
|
9
|
3
|
2
|
3
|
9
|
14
|
11
|
188
|
33
|
|
Participants Entering Follow Up Period
COMPLETED
|
3
|
6
|
4
|
6
|
9
|
3
|
2
|
3
|
9
|
13
|
10
|
159
|
28
|
|
Participants Entering Follow Up Period
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
29
|
5
|
Reasons for withdrawal
| Measure |
Part A: BMS-986156 10mg
BMS-986156 10mg Q2W
|
Part A: BMS-986156 30mg
BMS-986156 30mg Q2W
|
Part A: BMS-986156 100mg
BMS-986156 100mg Q2W
|
Part A: BMS-986156 240mg
BMS-986156 240mg Q2W
|
Part A: BMS-986156 800mg
BMS-986156 800mg Q2W
|
Part C: BMS-986156 240mg
BMS-986156 240mg Q2W
|
Part C: BMS-986156 800mg
BMS-986156 800mg Q2W
|
Part B: BMS-986156 30mg + Nivo 240mg
BMS986156 30mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 100mg + Nivo 240mg
BMS986156 100mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 240mg + Nivo 240mg
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 800mg + Nivo 240mg
BMS986156 800mg Q2W + Nivo 240mg Q2W
|
Part D: BMS-986156 240mg + Nivo 240mg
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part E: BMS-986156 480mg + Nivo 480mg
BMS986156 480mg Q4W + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period
Disease Progression
|
4
|
4
|
4
|
6
|
8
|
2
|
2
|
3
|
7
|
9
|
7
|
143
|
23
|
|
Treatment Period
Study drug toxicity
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
0
|
|
Treatment Period
Adverse Event unrelated to study drug
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
11
|
2
|
|
Treatment Period
participant request to discontinue
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
0
|
|
Treatment Period
participant withdrew consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Treatment Period
No longer meets study criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period
Other Reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Participants Entering Follow Up Period
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
11
|
2
|
|
Participants Entering Follow Up Period
participant withdrew consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
|
Participants Entering Follow Up Period
lost to follow up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Participants Entering Follow Up Period
follow up no longer required per protocol
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Participants Entering Follow Up Period
Other Reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
6
|
3
|
Baseline Characteristics
An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
Baseline characteristics by cohort
| Measure |
Part A: BMS-986156 10mg
n=4 Participants
BMS-986156 10mg Q2W
|
Part A: BMS-986156 30mg
n=6 Participants
BMS-986156 30mg Q2W
|
Part A: BMS-986156 100mg
n=4 Participants
BMS-986156 100mg Q2W
|
Part A: BMS-986156 240mg
n=6 Participants
BMS-986156 240mg Q2W
|
Part A: BMS-986156 800mg
n=9 Participants
BMS-986156 800mg Q2W
|
Part C: BMS-986156 240mg
n=3 Participants
BMS-986156 240mg Q2W
|
Part C: BMS-986156 800mg
n=2 Participants
BMS-986156 800mg Q2W
|
Part B: BMS-986156 30mg + Nivo 240mg
n=3 Participants
BMS986156 30mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 100mg + Nivo 240mg
n=9 Participants
BMS986156 100mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 240mg + Nivo 240mg
n=14 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 800mg + Nivo 240mg
n=11 Participants
BMS986156 800mg Q2W + Nivo 240mg Q2W
|
Part D: BMS-986156 240mg + Nivo 240mg
n=188 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part E: BMS-986156 480mg + Nivo 480mg
n=33 Participants
BMS986156 480mg Q4W + Nivo 480mg Q4W
|
Total
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.3 Years
STANDARD_DEVIATION 18.57 • n=5 Participants
|
59.7 Years
STANDARD_DEVIATION 5.82 • n=7 Participants
|
57.5 Years
STANDARD_DEVIATION 10.08 • n=5 Participants
|
49.5 Years
STANDARD_DEVIATION 13.28 • n=4 Participants
|
51.0 Years
STANDARD_DEVIATION 13.82 • n=21 Participants
|
58.3 Years
STANDARD_DEVIATION 19.43 • n=8 Participants
|
56.5 Years
STANDARD_DEVIATION 9.19 • n=8 Participants
|
50.7 Years
STANDARD_DEVIATION 20.50 • n=24 Participants
|
57.2 Years
STANDARD_DEVIATION 12.09 • n=42 Participants
|
55.6 Years
STANDARD_DEVIATION 18.67 • n=42 Participants
|
57.0 Years
STANDARD_DEVIATION 9.30 • n=42 Participants
|
59.0 Years
STANDARD_DEVIATION 11.58 • n=42 Participants
|
57.2 Years
STANDARD_DEVIATION 13.05 • n=36 Participants
|
57.9 Years
STANDARD_DEVIATION 12.31 • n=36 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
100 Participants
n=42 Participants
|
22 Participants
n=36 Participants
|
156 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
88 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
136 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
51 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
101 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
136 Participants
n=42 Participants
|
21 Participants
n=36 Participants
|
187 Participants
n=36 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 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
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
24 Participants
n=36 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
171 Participants
n=42 Participants
|
27 Participants
n=36 Participants
|
262 Participants
n=36 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 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
|
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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: From first treatment to 100 days post last dose. Approximately 29 monthsPopulation: All Treated Participants
Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths. AEs and laboratory values will be graded according to the NCI CTCAE version 4.03.
Outcome measures
| Measure |
Part A: BMS-986156 10mg
n=4 Participants
BMS-986156 10mg Q2W
|
Part A: BMS-986156 30mg
n=6 Participants
BMS-986156 30mg Q2W
|
Part A: BMS-986156 100mg
n=4 Participants
BMS-986156 100mg Q2W
|
Part A: BMS-986156 240mg
n=6 Participants
BMS-986156 240mg Q2W
|
Part A: BMS-986156 800mg
n=9 Participants
BMS-986156 800mg Q2W
|
Part C: BMS-986156 240mg
n=3 Participants
BMS-986156 240mg Q2W
|
Part C: BMS-986156 800mg
n=2 Participants
BMS-986156 800mg Q2W
|
Part B: BMS-986156 30mg + Nivo 240mg
n=3 Participants
BMS986156 30mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 100mg + Nivo 240mg
n=9 Participants
BMS986156 100mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 240mg + Nivo 240mg
n=14 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 800mg + Nivo 240mg
n=11 Participants
BMS986156 800mg Q2W + Nivo 240mg Q2W
|
Part D: BMS-986156 240mg + Nivo 240mg
n=188 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part E: BMS-986156 480mg + Nivo 480mg
n=33 Participants
BMS986156 480mg Q4W + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths
Adverse Events (AEs)
|
4 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
9 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
14 Participants
|
11 Participants
|
188 Participants
|
33 Participants
|
|
Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths
Serious Adverse Events (SAEs)
|
3 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
10 Participants
|
6 Participants
|
121 Participants
|
22 Participants
|
|
Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths
AEs leading to Discontinuation
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
32 Participants
|
5 Participants
|
|
Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths
Deaths
|
4 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
11 Participants
|
8 Participants
|
141 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: From first treatment to 100 days post last dose. Approximately 29 monthsPopulation: All treated participants with at least one on - treatment TSH measurement
Number of Participants with laboratory abnormalities in specific thyroid tests. TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number
Outcome measures
| Measure |
Part A: BMS-986156 10mg
n=4 Participants
BMS-986156 10mg Q2W
|
Part A: BMS-986156 30mg
n=6 Participants
BMS-986156 30mg Q2W
|
Part A: BMS-986156 100mg
n=4 Participants
BMS-986156 100mg Q2W
|
Part A: BMS-986156 240mg
n=6 Participants
BMS-986156 240mg Q2W
|
Part A: BMS-986156 800mg
n=9 Participants
BMS-986156 800mg Q2W
|
Part C: BMS-986156 240mg
n=3 Participants
BMS-986156 240mg Q2W
|
Part C: BMS-986156 800mg
n=2 Participants
BMS-986156 800mg Q2W
|
Part B: BMS-986156 30mg + Nivo 240mg
n=3 Participants
BMS986156 30mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 100mg + Nivo 240mg
n=9 Participants
BMS986156 100mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 240mg + Nivo 240mg
n=14 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 800mg + Nivo 240mg
n=11 Participants
BMS986156 800mg Q2W + Nivo 240mg Q2W
|
Part D: BMS-986156 240mg + Nivo 240mg
n=188 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part E: BMS-986156 480mg + Nivo 480mg
n=33 Participants
BMS986156 480mg Q4W + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
72 Participants
|
19 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN WITH TSH ≤ ULN AT BASELINE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
42 Participants
|
11 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
37 Participants
|
9 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
38 Participants
|
10 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH <LLN WITH TSH ≥ LLN AT BASELINE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
26 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
24 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From first treatment to 100 days post last dose. Approximately 29 monthsPopulation: All treated participants with at least one on - treatment liver test measurement
Number of Participants with laboratory abnormalities in specific liver tests. ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase
Outcome measures
| Measure |
Part A: BMS-986156 10mg
n=4 Participants
BMS-986156 10mg Q2W
|
Part A: BMS-986156 30mg
n=6 Participants
BMS-986156 30mg Q2W
|
Part A: BMS-986156 100mg
n=4 Participants
BMS-986156 100mg Q2W
|
Part A: BMS-986156 240mg
n=6 Participants
BMS-986156 240mg Q2W
|
Part A: BMS-986156 800mg
n=9 Participants
BMS-986156 800mg Q2W
|
Part C: BMS-986156 240mg
n=3 Participants
BMS-986156 240mg Q2W
|
Part C: BMS-986156 800mg
n=2 Participants
BMS-986156 800mg Q2W
|
Part B: BMS-986156 30mg + Nivo 240mg
n=3 Participants
BMS986156 30mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 100mg + Nivo 240mg
n=9 Participants
BMS986156 100mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 240mg + Nivo 240mg
n=13 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 800mg + Nivo 240mg
n=11 Participants
BMS986156 800mg Q2W + Nivo 240mg Q2W
|
Part D: BMS-986156 240mg + Nivo 240mg
n=188 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part E: BMS-986156 480mg + Nivo 480mg
n=33 Participants
BMS986156 480mg Q4W + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST > 20*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST > 3*ULN
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
25 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST> 5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
14 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST> 10*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
TOTAL BILIRUBIN > 2*ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALP > 1.5*ULN
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
70 Participants
|
11 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose to a response or progressive disease (Approximately 50 Months)Population: All treated participants
BOR will be defined by CR, PR, PD and SD Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Part A: BMS-986156 10mg
n=4 Participants
BMS-986156 10mg Q2W
|
Part A: BMS-986156 30mg
n=6 Participants
BMS-986156 30mg Q2W
|
Part A: BMS-986156 100mg
n=4 Participants
BMS-986156 100mg Q2W
|
Part A: BMS-986156 240mg
n=6 Participants
BMS-986156 240mg Q2W
|
Part A: BMS-986156 800mg
n=9 Participants
BMS-986156 800mg Q2W
|
Part C: BMS-986156 240mg
n=3 Participants
BMS-986156 240mg Q2W
|
Part C: BMS-986156 800mg
n=2 Participants
BMS-986156 800mg Q2W
|
Part B: BMS-986156 30mg + Nivo 240mg
n=3 Participants
BMS986156 30mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 100mg + Nivo 240mg
n=9 Participants
BMS986156 100mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 240mg + Nivo 240mg
n=14 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 800mg + Nivo 240mg
n=11 Participants
BMS986156 800mg Q2W + Nivo 240mg Q2W
|
Part D: BMS-986156 240mg + Nivo 240mg
n=188 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part E: BMS-986156 480mg + Nivo 480mg
n=33 Participants
BMS986156 480mg Q4W + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Best Overall Response
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
17 Participants
|
1 Participants
|
|
Best Overall Response
Stable Disease
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
59 Participants
|
12 Participants
|
|
Best Overall Response
Progressive Disease
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
91 Participants
|
15 Participants
|
|
Best Overall Response
Not Evaluable
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
16 Participants
|
3 Participants
|
|
Best Overall Response
Not Available
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose to CR and PR (Approximately 50 Months)Population: All treated participants
Defined as the percentage of all treated participants whose BOR is either a complete response(CR) or partial response(PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part A: BMS-986156 10mg
n=4 Participants
BMS-986156 10mg Q2W
|
Part A: BMS-986156 30mg
n=6 Participants
BMS-986156 30mg Q2W
|
Part A: BMS-986156 100mg
n=4 Participants
BMS-986156 100mg Q2W
|
Part A: BMS-986156 240mg
n=6 Participants
BMS-986156 240mg Q2W
|
Part A: BMS-986156 800mg
n=9 Participants
BMS-986156 800mg Q2W
|
Part C: BMS-986156 240mg
n=3 Participants
BMS-986156 240mg Q2W
|
Part C: BMS-986156 800mg
n=2 Participants
BMS-986156 800mg Q2W
|
Part B: BMS-986156 30mg + Nivo 240mg
n=3 Participants
BMS986156 30mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 100mg + Nivo 240mg
n=9 Participants
BMS986156 100mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 240mg + Nivo 240mg
n=14 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 800mg + Nivo 240mg
n=11 Participants
BMS986156 800mg Q2W + Nivo 240mg Q2W
|
Part D: BMS-986156 240mg + Nivo 240mg
n=188 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part E: BMS-986156 480mg + Nivo 480mg
n=33 Participants
BMS986156 480mg Q4W + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 45.9
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 45.9
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 84.2
|
0 Percentage of participants
Interval 0.0 to 70.8
|
11.1 Percentage of participants
Interval 0.3 to 48.2
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
9.1 Percentage of participants
Interval 0.2 to 41.3
|
11.2 Percentage of participants
Interval 7.0 to 16.6
|
9.1 Percentage of participants
Interval 1.9 to 24.3
|
SECONDARY outcome
Timeframe: From first dose to disease progression (Approximately 50 Months)Population: All treated participants with evaluable PFS measures
The time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Part A: BMS-986156 10mg
n=4 Participants
BMS-986156 10mg Q2W
|
Part A: BMS-986156 30mg
n=6 Participants
BMS-986156 30mg Q2W
|
Part A: BMS-986156 100mg
n=4 Participants
BMS-986156 100mg Q2W
|
Part A: BMS-986156 240mg
n=6 Participants
BMS-986156 240mg Q2W
|
Part A: BMS-986156 800mg
n=9 Participants
BMS-986156 800mg Q2W
|
Part C: BMS-986156 240mg
n=3 Participants
BMS-986156 240mg Q2W
|
Part C: BMS-986156 800mg
n=2 Participants
BMS-986156 800mg Q2W
|
Part B: BMS-986156 30mg + Nivo 240mg
n=3 Participants
BMS986156 30mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 100mg + Nivo 240mg
n=9 Participants
BMS986156 100mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 240mg + Nivo 240mg
n=14 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 800mg + Nivo 240mg
n=11 Participants
BMS986156 800mg Q2W + Nivo 240mg Q2W
|
Part D: BMS-986156 240mg + Nivo 240mg
n=188 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part E: BMS-986156 480mg + Nivo 480mg
n=33 Participants
BMS986156 480mg Q4W + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
3.48 Months
Interval 1.64 to
Insufficient number of events to calculate
|
1.74 Months
Interval 1.45 to
Insufficient number of events to calculate
|
2.66 Months
Interval 1.64 to
Insufficient number of events to calculate
|
1.64 Months
Interval 1.58 to
Insufficient number of events to calculate
|
1.84 Months
Interval 1.64 to 3.48
|
1.64 Months
Interval 1.64 to
Insufficient number of events to calculate
|
1.71 Months
Insufficient number of events to calculate
|
1.81 Months
Interval 1.64 to
Insufficient number of events to calculate
|
1.64 Months
Interval 0.89 to 22.47
|
3.71 Months
Interval 1.64 to 8.97
|
3.52 Months
Interval 1.61 to
Insufficient number of events to calculate
|
1.91 Months
Interval 1.81 to 3.25
|
2.92 Months
Interval 1.77 to 3.52
|
SECONDARY outcome
Timeframe: From first dose to disease progression after a response (Approximately 50 Months)Population: All treated participants with a CR or PR
All treated participants with a BOR of CR or PR, is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part A: BMS-986156 10mg
BMS-986156 10mg Q2W
|
Part A: BMS-986156 30mg
BMS-986156 30mg Q2W
|
Part A: BMS-986156 100mg
BMS-986156 100mg Q2W
|
Part A: BMS-986156 240mg
BMS-986156 240mg Q2W
|
Part A: BMS-986156 800mg
BMS-986156 800mg Q2W
|
Part C: BMS-986156 240mg
BMS-986156 240mg Q2W
|
Part C: BMS-986156 800mg
BMS-986156 800mg Q2W
|
Part B: BMS-986156 30mg + Nivo 240mg
BMS986156 30mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 100mg + Nivo 240mg
n=1 Participants
BMS986156 100mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 240mg + Nivo 240mg
n=3 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 800mg + Nivo 240mg
n=1 Participants
BMS986156 800mg Q2W + Nivo 240mg Q2W
|
Part D: BMS-986156 240mg + Nivo 240mg
n=20 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part E: BMS-986156 480mg + Nivo 480mg
n=3 Participants
BMS986156 480mg Q4W + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
20.70 Months
Interval 20.7 to 20.7
|
30.10 Months
Interval 7.4 to 31.3
|
NA Months
Interval 31.0 to 31.0
Insufficient number of events to calculate
|
NA Months
Interval 0.0 to 31.8
Insufficient number of events to calculate
|
NA Months
Interval 21.0 to 22.4
Insufficient number of events to calculate
|
SECONDARY outcome
Timeframe: At Cycle 3 Day 1; where each treatment cycle was 8 weeksPopulation: All BMS-986156 or Nivolumab Treated participants with Baseline and at Least One Post-baseline Assessment
Number of participants with a positive Anti-Drug Antibody to BMS-986156 or nivolumab
Outcome measures
| Measure |
Part A: BMS-986156 10mg
n=4 Participants
BMS-986156 10mg Q2W
|
Part A: BMS-986156 30mg
n=6 Participants
BMS-986156 30mg Q2W
|
Part A: BMS-986156 100mg
n=4 Participants
BMS-986156 100mg Q2W
|
Part A: BMS-986156 240mg
n=6 Participants
BMS-986156 240mg Q2W
|
Part A: BMS-986156 800mg
n=9 Participants
BMS-986156 800mg Q2W
|
Part C: BMS-986156 240mg
n=3 Participants
BMS-986156 240mg Q2W
|
Part C: BMS-986156 800mg
n=2 Participants
BMS-986156 800mg Q2W
|
Part B: BMS-986156 30mg + Nivo 240mg
n=3 Participants
BMS986156 30mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 100mg + Nivo 240mg
n=9 Participants
BMS986156 100mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 240mg + Nivo 240mg
n=14 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part B: BMS-986156 800mg + Nivo 240mg
n=11 Participants
BMS986156 800mg Q2W + Nivo 240mg Q2W
|
Part D: BMS-986156 240mg + Nivo 240mg
n=188 Participants
BMS986156 240mg Q2W + Nivo 240mg Q2W
|
Part E: BMS-986156 480mg + Nivo 480mg
n=33 Participants
BMS986156 480mg Q4W + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-Drug Antibody Response
BMS-986156
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibody Response
Nivolumab
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
32 Participants
|
2 Participants
|
Adverse Events
Part A: BMS-986156 10mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Part A: BMS-986156 30mg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 5 deaths
Part A: BMS-986156 100mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Part A: BMS-986156 240mg
Serious events: 5 serious events
Other events: 6 other events
Deaths: 5 deaths
Part A: BMS-986156 800mg
Serious events: 4 serious events
Other events: 9 other events
Deaths: 6 deaths
Part C: BMS-986156 240mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Part C: BMS-986156 800mg
Serious events: 2 serious events
Other events: 1 other events
Deaths: 2 deaths
Part B: BMS-986156 30mg +Nivo 240mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 3 deaths
Part B: BMS-986156 100mg +Nivo 240mg
Serious events: 5 serious events
Other events: 8 other events
Deaths: 6 deaths
Part B: BMS-986156 240mg +Nivo 240mg
Serious events: 10 serious events
Other events: 14 other events
Deaths: 11 deaths
Part B: BMS-986156 800mg +Nivo 240mg
Serious events: 6 serious events
Other events: 11 other events
Deaths: 8 deaths
Part D: BMS-986156 240mg +Nivo 240mg
Serious events: 121 serious events
Other events: 185 other events
Deaths: 141 deaths
Part E: BMS-986156 480mg +Nivo 480mg
Serious events: 22 serious events
Other events: 31 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Part A: BMS-986156 10mg
n=4 participants at risk
BMS-986156 10mg Q2W
|
Part A: BMS-986156 30mg
n=6 participants at risk
Part A: BMS-986156 30mg Q2W
|
Part A: BMS-986156 100mg
n=4 participants at risk
BMS-986156 100mg Q2W
|
Part A: BMS-986156 240mg
n=6 participants at risk
Part A: BMS-986156 240mg Q2W
|
Part A: BMS-986156 800mg
n=9 participants at risk
BMS-986156 800mg Q2W
|
Part C: BMS-986156 240mg
n=3 participants at risk
BMS-986156 240mg Q2W
|
Part C: BMS-986156 800mg
n=2 participants at risk
BMS-986156 800mg Q2W
|
Part B: BMS-986156 30mg +Nivo 240mg
n=3 participants at risk
BMS-986156 30mg Q2W +Nivo 240mg Q2W
|
Part B: BMS-986156 100mg +Nivo 240mg
n=9 participants at risk
BMS-986156 100mg Q2W +Nivo 240mg Q2W
|
Part B: BMS-986156 240mg +Nivo 240mg
n=14 participants at risk
BMS-986156 240mg Q2W +Nivo 240mg Q2W
|
Part B: BMS-986156 800mg +Nivo 240mg
n=11 participants at risk
BMS-986156 800mg Q2W +Nivo 240mg Q2W
|
Part D: BMS-986156 240mg +Nivo 240mg
n=188 participants at risk
BMS-986156 240mg Q2W +Nivo 240mg Q2W
|
Part E: BMS-986156 480mg +Nivo 480mg
n=33 participants at risk
BMS-986156 480mg Q4W +Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Endocrine disorders
Ectopic antidiuretic hormone secretion
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Cardiac disorders
Endocarditis noninfective
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
3/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.6%
3/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.6%
3/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Disease progression
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Fatigue
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Inflammation
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.7%
7/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Performance status decreased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Pyrexia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Hepatobiliary infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Kidney infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.6%
3/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Stoma obstruction
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Stoma site extravasation
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
General physical condition abnormal
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.6%
3/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
75.0%
3/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
2/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
2/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
3/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
100.0%
2/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
66.7%
2/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
3/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
28.6%
4/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
2/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
38.3%
72/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
39.4%
13/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pancreas
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
50.0%
1/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Ureteric haemorrhage
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.6%
3/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Urogenital fistula
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
Other adverse events
| Measure |
Part A: BMS-986156 10mg
n=4 participants at risk
BMS-986156 10mg Q2W
|
Part A: BMS-986156 30mg
n=6 participants at risk
Part A: BMS-986156 30mg Q2W
|
Part A: BMS-986156 100mg
n=4 participants at risk
BMS-986156 100mg Q2W
|
Part A: BMS-986156 240mg
n=6 participants at risk
Part A: BMS-986156 240mg Q2W
|
Part A: BMS-986156 800mg
n=9 participants at risk
BMS-986156 800mg Q2W
|
Part C: BMS-986156 240mg
n=3 participants at risk
BMS-986156 240mg Q2W
|
Part C: BMS-986156 800mg
n=2 participants at risk
BMS-986156 800mg Q2W
|
Part B: BMS-986156 30mg +Nivo 240mg
n=3 participants at risk
BMS-986156 30mg Q2W +Nivo 240mg Q2W
|
Part B: BMS-986156 100mg +Nivo 240mg
n=9 participants at risk
BMS-986156 100mg Q2W +Nivo 240mg Q2W
|
Part B: BMS-986156 240mg +Nivo 240mg
n=14 participants at risk
BMS-986156 240mg Q2W +Nivo 240mg Q2W
|
Part B: BMS-986156 800mg +Nivo 240mg
n=11 participants at risk
BMS-986156 800mg Q2W +Nivo 240mg Q2W
|
Part D: BMS-986156 240mg +Nivo 240mg
n=188 participants at risk
BMS-986156 240mg Q2W +Nivo 240mg Q2W
|
Part E: BMS-986156 480mg +Nivo 480mg
n=33 participants at risk
BMS-986156 480mg Q4W +Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Otitis externa
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Otitis media
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
3/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.6%
3/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Vascular disorders
Vascular compression
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
21.4%
3/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
2/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.0%
30/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
15.2%
5/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
5.3%
10/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
5.9%
11/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
3/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Eye disorders
Eye discharge
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Eye disorders
Periorbital swelling
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.6%
3/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
5.3%
10/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
50.0%
3/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
2/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
3/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
21.4%
3/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
2/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.7%
22/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
27.3%
9/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
4.3%
8/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
5.3%
10/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
2/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
2/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
22.2%
2/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
3/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
2/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.9%
28/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
21.2%
7/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
44.4%
4/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
28.6%
4/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
27.3%
3/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.6%
35/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
6/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
6/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.6%
3/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.7%
7/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
50.0%
3/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
50.0%
3/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
22.2%
2/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
44.4%
4/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
35.7%
5/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
45.5%
5/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
23.4%
44/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
36.4%
12/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
12.1%
4/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
3/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
57.1%
8/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
2/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.9%
28/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
24.2%
8/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Asthenia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.4%
27/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Catheter site erythema
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Chest pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
5.9%
11/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Chills
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
22.2%
2/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
28.6%
4/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
2/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
8.0%
15/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Early satiety
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Fatigue
|
50.0%
2/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
2/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
2/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
3/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
66.7%
2/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
50.0%
1/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
35.7%
5/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
63.6%
7/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
30.3%
57/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
45.5%
15/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Feeling abnormal
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Feeling hot
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
5.9%
11/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Malaise
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
2/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
2/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
22.2%
2/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
50.0%
1/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
27.3%
3/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
13.3%
25/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
6/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.0%
17/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
General disorders
Pyrexia
|
50.0%
2/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
50.0%
3/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
3/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
66.7%
2/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
3/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
35.7%
5/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
45.5%
5/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.1%
34/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
3/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
50.0%
1/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Epididymitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Furuncle
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Gingivitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
2/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
4.3%
8/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
22.2%
2/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
5.9%
11/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
12.1%
4/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
50.0%
1/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
2/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
10.6%
20/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
6/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
4.3%
8/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Amylase increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.7%
7/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
5.9%
11/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.6%
3/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
5.9%
11/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Lipase increased
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.7%
7/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Weight decreased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
22.2%
2/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
4.8%
9/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Investigations
Weight increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
2/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
22.2%
2/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
50.0%
1/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
35.7%
5/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
36.4%
4/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.1%
34/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
15.2%
5/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.7%
7/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.7%
7/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
4.8%
9/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
22.2%
2/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
21.4%
3/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
27.3%
3/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
10.6%
20/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
15.2%
5/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
2/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
45.5%
5/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
13.3%
25/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
12.1%
4/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.6%
3/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
4.3%
8/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
15.2%
5/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
4.8%
9/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
3/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
2/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
22.2%
2/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
36.4%
4/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
5.9%
11/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
8.0%
15/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
12.1%
4/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
5.9%
11/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
50.0%
1/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
5.9%
11/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
5.3%
10/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
22.2%
2/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
35.7%
5/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
27.3%
3/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.7%
22/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
3/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
28.6%
4/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
21.4%
3/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.7%
7/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
21.4%
3/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.4%
12/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Kidney congestion
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
2/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.6%
3/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
22.2%
2/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
35.7%
5/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.5%
31/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
21.2%
7/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
22.2%
2/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
50.0%
1/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
2/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
15.4%
29/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
6/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
3/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.7%
5/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
3/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.7%
7/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
3/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.7%
7/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
12.1%
4/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.6%
3/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
2.1%
4/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.7%
7/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
18.2%
2/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.2%
21/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.0%
1/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
14.3%
2/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
8.0%
15/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
3/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
9.1%
1/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
1.1%
2/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
3.2%
6/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
16.7%
1/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
7.1%
1/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.53%
1/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/6 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/2 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
11.1%
1/9 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/14 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/11 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
0.00%
0/188 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
6.1%
2/33 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60