Trial Outcomes & Findings for An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma (NCT NCT02253992)
NCT ID: NCT02253992
Last Updated: 2020-10-05
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
232 participants
Primary outcome timeframe
From day 1 until 100 days after participant last dose of study drug.
Results posted on
2020-10-05
Participant Flow
160 enrolled and treated
Participant milestones
| Measure |
TRT A
URE3 Q4WK+NIV3 Q2WK
|
TRT B
URE8 Q4WK+NIV3 Q2WK
|
TRT D
URE8 Q4WK+NIV240mg Q2WK
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
150
|
|
Overall Study
COMPLETED
|
0
|
0
|
6
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
144
|
Reasons for withdrawal
| Measure |
TRT A
URE3 Q4WK+NIV3 Q2WK
|
TRT B
URE8 Q4WK+NIV3 Q2WK
|
TRT D
URE8 Q4WK+NIV240mg Q2WK
|
|---|---|---|---|
|
Overall Study
Study drug toxicity
|
1
|
0
|
10
|
|
Overall Study
Disease progression
|
4
|
3
|
98
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
3
|
|
Overall Study
Adverse Event
|
0
|
0
|
8
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Subject discontinued study drug
|
1
|
0
|
1
|
|
Overall Study
Completed treatment as per protocol
|
0
|
1
|
22
|
|
Overall Study
Other
|
0
|
0
|
1
|
Baseline Characteristics
An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
TRT A
n=6 Participants
URE3 Q4WK+NIV3 Q2WK
|
TRT B
n=4 Participants
URE8 Q4WK+NIV3 Q2WK
|
TRT D
n=150 Participants
URE8 Q4WK+NIV240mg Q2WK
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Age, Continuous
|
64.7 Years
STANDARD_DEVIATION 9.40 • n=5 Participants
|
64.0 Years
STANDARD_DEVIATION 8.52 • n=7 Participants
|
63.8 Years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
63.9 Years
STANDARD_DEVIATION 11.52 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
44 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
146 Participants
n=4 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From day 1 until 100 days after participant last dose of study drug.Population: All treated participants
Outcome measures
| Measure |
TRT A
n=6 Participants
URE3 Q4WK+NIV3 Q2WK
|
TRT B
n=4 Participants
URE8 Q4WK+NIV3 Q2WK
|
TRT D
n=150 Participants
URE8 Q4WK+NIV240mg Q2WK
|
TRT A - Melanoma pd1/Pd-l1 Naive
URE3 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
|
TRT B -
URE8 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
|
TRT D - Melanoma pd1/Pd-l1 Naive
URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 naive
|
TRT A - SCCHN
URE3 Q4WK+NIV3 Q2WK - Squamous cell carcinoma of head and neck.
|
TRT D - SCCHN
URE8 Q4WK+NIV240mg Q2WK - Squamous cell carcinoma of head and neck.
|
TRT A - Other Solid Tumors
URE3 Q4WK+NIV3 Q2WK - Other solid tumors
|
TRT B - Other Solid Tumors
URE8 Q4WK+NIV3 Q2WK - Other Solid tumors.
|
TRT D - DLBCL
URE8 Q4WK+NIV240mg Q2WK - Diffuse Large B-cell lymphoma.
|
TRT D - FL
URE8 Q4WK+NIV240mg Q2WK - Follicular Lymphoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Incidence of Adverse Events.
|
6 Number of participants
|
4 Number of participants
|
150 Number of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From day 1 until 100 days after participant last dose of the study drug.Population: All treated participants
Outcome measures
| Measure |
TRT A
n=6 Participants
URE3 Q4WK+NIV3 Q2WK
|
TRT B
n=4 Participants
URE8 Q4WK+NIV3 Q2WK
|
TRT D
n=150 Participants
URE8 Q4WK+NIV240mg Q2WK
|
TRT A - Melanoma pd1/Pd-l1 Naive
URE3 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
|
TRT B -
URE8 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
|
TRT D - Melanoma pd1/Pd-l1 Naive
URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 naive
|
TRT A - SCCHN
URE3 Q4WK+NIV3 Q2WK - Squamous cell carcinoma of head and neck.
|
TRT D - SCCHN
URE8 Q4WK+NIV240mg Q2WK - Squamous cell carcinoma of head and neck.
|
TRT A - Other Solid Tumors
URE3 Q4WK+NIV3 Q2WK - Other solid tumors
|
TRT B - Other Solid Tumors
URE8 Q4WK+NIV3 Q2WK - Other Solid tumors.
|
TRT D - DLBCL
URE8 Q4WK+NIV240mg Q2WK - Diffuse Large B-cell lymphoma.
|
TRT D - FL
URE8 Q4WK+NIV240mg Q2WK - Follicular Lymphoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Incidence of Seriuos Adverse Events.
|
3 Number of participants
|
3 Number of participants
|
86 Number of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From day 1 until 100 days after participant last dose of study drug.Population: All Treated participants
Outcome measures
| Measure |
TRT A
n=6 Participants
URE3 Q4WK+NIV3 Q2WK
|
TRT B
n=4 Participants
URE8 Q4WK+NIV3 Q2WK
|
TRT D
n=150 Participants
URE8 Q4WK+NIV240mg Q2WK
|
TRT A - Melanoma pd1/Pd-l1 Naive
URE3 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
|
TRT B -
URE8 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
|
TRT D - Melanoma pd1/Pd-l1 Naive
URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 naive
|
TRT A - SCCHN
URE3 Q4WK+NIV3 Q2WK - Squamous cell carcinoma of head and neck.
|
TRT D - SCCHN
URE8 Q4WK+NIV240mg Q2WK - Squamous cell carcinoma of head and neck.
|
TRT A - Other Solid Tumors
URE3 Q4WK+NIV3 Q2WK - Other solid tumors
|
TRT B - Other Solid Tumors
URE8 Q4WK+NIV3 Q2WK - Other Solid tumors.
|
TRT D - DLBCL
URE8 Q4WK+NIV240mg Q2WK - Diffuse Large B-cell lymphoma.
|
TRT D - FL
URE8 Q4WK+NIV240mg Q2WK - Follicular Lymphoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Incidence of Death.
|
6 Number of participants
|
2 Number of participants
|
93 Number of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.Population: All treated Participants
The total number of subjects whose best overall response (BOR) is either a complete response or partial response for solid tumors and complete remission or partial remission for B-cell NHL, divided by the total number of subjects in the population of interest.
Outcome measures
| Measure |
TRT A
n=20 Participants
URE3 Q4WK+NIV3 Q2WK
|
TRT B
n=20 Participants
URE8 Q4WK+NIV3 Q2WK
|
TRT D
n=20 Participants
URE8 Q4WK+NIV240mg Q2WK
|
TRT A - Melanoma pd1/Pd-l1 Naive
n=4 Participants
URE3 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
|
TRT B -
n=1 Participants
URE8 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
|
TRT D - Melanoma pd1/Pd-l1 Naive
n=43 Participants
URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 naive
|
TRT A - SCCHN
n=1 Participants
URE3 Q4WK+NIV3 Q2WK - Squamous cell carcinoma of head and neck.
|
TRT D - SCCHN
n=21 Participants
URE8 Q4WK+NIV240mg Q2WK - Squamous cell carcinoma of head and neck.
|
TRT A - Other Solid Tumors
n=1 Participants
URE3 Q4WK+NIV3 Q2WK - Other solid tumors
|
TRT B - Other Solid Tumors
n=3 Participants
URE8 Q4WK+NIV3 Q2WK - Other Solid tumors.
|
TRT D - DLBCL
n=22 Participants
URE8 Q4WK+NIV240mg Q2WK - Diffuse Large B-cell lymphoma.
|
TRT D - FL
n=4 Participants
URE8 Q4WK+NIV240mg Q2WK - Follicular Lymphoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response (BOR)
Partial response
|
1 Number of participants
|
1 Number of participants
|
2 Number of participants
|
1 Number of participants
|
0 Number of participants
|
15 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Best Overall Response (BOR)
Complete response
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
6 Number of participants
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
SECONDARY outcome
Timeframe: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.Population: All treated Participants
Objective response rate (ORR) is defined as the total number of subjects whose BOR is either CR or PR divided by the total number of subjects in the population of interest.
Outcome measures
| Measure |
TRT A
n=20 Participants
URE3 Q4WK+NIV3 Q2WK
|
TRT B
n=20 Participants
URE8 Q4WK+NIV3 Q2WK
|
TRT D
n=20 Participants
URE8 Q4WK+NIV240mg Q2WK
|
TRT A - Melanoma pd1/Pd-l1 Naive
n=4 Participants
URE3 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
|
TRT B -
n=1 Participants
URE8 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
|
TRT D - Melanoma pd1/Pd-l1 Naive
n=43 Participants
URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 naive
|
TRT A - SCCHN
n=1 Participants
URE3 Q4WK+NIV3 Q2WK - Squamous cell carcinoma of head and neck.
|
TRT D - SCCHN
n=21 Participants
URE8 Q4WK+NIV240mg Q2WK - Squamous cell carcinoma of head and neck.
|
TRT A - Other Solid Tumors
n=1 Participants
URE3 Q4WK+NIV3 Q2WK - Other solid tumors
|
TRT B - Other Solid Tumors
n=3 Participants
URE8 Q4WK+NIV3 Q2WK - Other Solid tumors.
|
TRT D - DLBCL
n=22 Participants
URE8 Q4WK+NIV240mg Q2WK - Diffuse Large B-cell lymphoma.
|
TRT D - FL
n=4 Participants
URE8 Q4WK+NIV240mg Q2WK - Follicular Lymphoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
48.8 Percentage of participants
Interval 33.3 to 64.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 60.2
|
SECONDARY outcome
Timeframe: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.Population: All treated participants
Outcome measures
| Measure |
TRT A
n=133 Participants
URE3 Q4WK+NIV3 Q2WK
|
TRT B
n=128 Participants
URE8 Q4WK+NIV3 Q2WK
|
TRT D
URE8 Q4WK+NIV240mg Q2WK
|
TRT A - Melanoma pd1/Pd-l1 Naive
URE3 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
|
TRT B -
URE8 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
|
TRT D - Melanoma pd1/Pd-l1 Naive
URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 naive
|
TRT A - SCCHN
URE3 Q4WK+NIV3 Q2WK - Squamous cell carcinoma of head and neck.
|
TRT D - SCCHN
URE8 Q4WK+NIV240mg Q2WK - Squamous cell carcinoma of head and neck.
|
TRT A - Other Solid Tumors
URE3 Q4WK+NIV3 Q2WK - Other solid tumors
|
TRT B - Other Solid Tumors
URE8 Q4WK+NIV3 Q2WK - Other Solid tumors.
|
TRT D - DLBCL
URE8 Q4WK+NIV240mg Q2WK - Diffuse Large B-cell lymphoma.
|
TRT D - FL
URE8 Q4WK+NIV240mg Q2WK - Follicular Lymphoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Occurrence of Specific Anti-drug Antibodies (ADA) to Urelumab and Nivolumab
Baseline ADA positive
|
5 Number of participants
|
2 Number of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Specific Anti-drug Antibodies (ADA) to Urelumab and Nivolumab
ADA positive
|
55 Number of participants
|
9 Number of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Specific Anti-drug Antibodies (ADA) to Urelumab and Nivolumab
ADA negative
|
78 Number of participants
|
119 Number of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 yearsPopulation: Data was not collected due to discontinuation of the study/Due to study termination.
DOR is defined as the number of days between the date of first response and the subsequent date of objectively documented disease progression based on the criteria (RECIST v1.1) or relapse based on IWG, or death due to any cause, if death occurred within 100 days after last dose, whichever occurs first. Data was not collected due to discontinuation of the study/Due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.Population: Data was not collected due to discontinuation of the study/Due to study termination.
PFSR is defined as the probability of a subject remaining progression-free and surviving a specific length of time. Data was not collected due to discontinuation of the study/Due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.Population: Data was not collected due to discontinuation of the study/Due to study termination.
Data was not collected due to discontinuation of the study/Due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.Population: Data was not collected due to discontinuation of the study/Due to study termination.
Data was not collected due to discontinuation of the study/Due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 daysPopulation: Data was not collected due to discontinuation of the study/Due to study termination.
Data was not collected due to discontinuation of the study/Due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.Population: Data was not collected due to discontinuation of the study/Due to study termination.
Data was not collected due to discontinuation of the study/Due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.Population: Data was not collected due to discontinuation of the study/Due to study termination.
Data was not collected due to discontinuation of the study/Due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.Population: Data was not collected due to discontinuation of the study/Due to study termination.
Data was not collected due to discontinuation of the study/Due to study termination.
Outcome measures
Outcome data not reported
Adverse Events
TRT A
Serious events: 3 serious events
Other events: 6 other events
Deaths: 6 deaths
TRT B
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
TRT D
Serious events: 86 serious events
Other events: 147 other events
Deaths: 93 deaths
Serious adverse events
| Measure |
TRT A
n=6 participants at risk
URE3 Q4WK+NIV3 Q2WK
|
TRT B
n=4 participants at risk
URE8 Q4WK+NIV3 Q2WK
|
TRT D
n=150 participants at risk
URE8 Q4WK+NIV240mg Q2WK
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Enteritis
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Ileus
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Asthenia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Fatigue
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
General physical health deterioration
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.7%
4/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Hyperthermia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Hypothermia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Pain
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.7%
4/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Pelvic mass
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
3.3%
5/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Sudden death
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Hepatobiliary disorders
Bile duct stenosis
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.7%
4/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
24.7%
37/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Psychiatric disorders
Persistent depressive disorder
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Renal and urinary disorders
Hydronephrosis
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.7%
4/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Vascular disorders
Embolism
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
Other adverse events
| Measure |
TRT A
n=6 participants at risk
URE3 Q4WK+NIV3 Q2WK
|
TRT B
n=4 participants at risk
URE8 Q4WK+NIV3 Q2WK
|
TRT D
n=150 participants at risk
URE8 Q4WK+NIV240mg Q2WK
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
3/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
31.3%
47/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
5.3%
8/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Endocrine disorders
Adrenal insufficiency
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
10.7%
16/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
3.3%
5/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Eye disorders
Vision blurred
|
33.3%
2/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
4.0%
6/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
12.7%
19/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
4.0%
6/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Anal incontinence
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
20.7%
31/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Diarrhoea
|
83.3%
5/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
21.3%
32/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
5.3%
8/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
2/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
4.0%
6/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Melaena
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
24.7%
37/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
17.3%
26/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Asthenia
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
10.7%
16/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Chills
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
9.3%
14/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Fatigue
|
66.7%
4/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
50.0%
2/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
40.7%
61/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Gait disturbance
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
16.7%
25/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Performance status decreased
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
General disorders
Pyrexia
|
66.7%
4/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
19.3%
29/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Gastroenteritis
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Gingivitis
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Localised infection
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
4.0%
6/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.7%
4/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
8.0%
12/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
8.0%
12/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
5.3%
8/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
17.3%
26/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Amylase increased
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
8.7%
13/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
17.3%
26/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
2/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
13.3%
20/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
5.3%
8/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.7%
4/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Blood uric acid decreased
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
2/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
12.0%
18/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Lipase increased
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
11.3%
17/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Lymphocyte count decreased
|
33.3%
2/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
4.7%
7/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
5.3%
8/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Investigations
Weight decreased
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
12.0%
18/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
16.0%
24/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.7%
4/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
5.3%
8/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
9.3%
14/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
7.3%
11/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
8.0%
12/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
6.0%
9/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.7%
4/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
9.3%
14/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
2/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
10.7%
16/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
50.0%
2/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
11.3%
17/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
15.3%
23/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
2/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
3.3%
5/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
7.3%
11/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
10.0%
15/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
4.0%
6/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
10.0%
15/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
8.7%
13/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Headache
|
66.7%
4/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
15.3%
23/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Nervous system disorders
Sinus headache
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
7.3%
11/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
7.3%
11/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Renal and urinary disorders
Pollakiuria
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
4.0%
6/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
22.0%
33/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
17.3%
26/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
4.0%
6/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
3.3%
5/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
8.7%
13/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
50.0%
2/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
14.7%
22/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
10.7%
16/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
50.0%
2/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
6.0%
9/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
25.0%
1/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
1.3%
2/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Vascular disorders
Hot flush
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.67%
1/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
2.0%
3/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
0.00%
0/4 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
4.0%
6/150 • From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
|
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