Trial Outcomes & Findings for Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck (NCT NCT02319044)
NCT ID: NCT02319044
Last Updated: 2020-09-29
Results Overview
Objective response rate, primary analysis, based on BICR assessments according to RECIST v1.1. The number (%) of patients with a response excludes unconfirmed responses
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
267 participants
Primary outcome timeframe
After 6 months
Results posted on
2020-09-29
Participant Flow
127 sites in 15 countries enrolled and screened patients. The study was conducted and managed by PRA, a contract research organization.
Participant milestones
| Measure |
MEDI4736 AND TREMELIMUMAB COMBINATION
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
|---|---|---|---|
|
Overall Study
STARTED
|
133
|
67
|
67
|
|
Overall Study
COMPLETED
|
11
|
7
|
0
|
|
Overall Study
NOT COMPLETED
|
122
|
60
|
67
|
Reasons for withdrawal
| Measure |
MEDI4736 AND TREMELIMUMAB COMBINATION
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
|---|---|---|---|
|
Overall Study
Death, PI/sponsor decision, med history
|
0
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
6
|
|
Overall Study
Condition under investigation worsened
|
100
|
50
|
46
|
|
Overall Study
Adverse Event
|
17
|
2
|
8
|
|
Overall Study
Study specific discontinuation criteria
|
2
|
2
|
1
|
|
Overall Study
Not treated
|
0
|
2
|
2
|
Baseline Characteristics
Full analysis set - all randomized patients
Baseline characteristics by cohort
| Measure |
MEDI4736 + Tremelimumab
n=133 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=67 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=67 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants • Full analysis set - all randomized patients
|
0 Participants
n=4 Participants • Full analysis set - all randomized patients
|
0 Participants
n=27 Participants • Full analysis set - all randomized patients
|
0 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=93 Participants • Full analysis set - all randomized patients
|
46 Participants
n=4 Participants • Full analysis set - all randomized patients
|
42 Participants
n=27 Participants • Full analysis set - all randomized patients
|
176 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Age, Categorical
>=65 years
|
45 Participants
n=93 Participants • Full analysis set - all randomized patients
|
21 Participants
n=4 Participants • Full analysis set - all randomized patients
|
25 Participants
n=27 Participants • Full analysis set - all randomized patients
|
91 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Age, Continuous
|
62 years
n=93 Participants • Full analysis set - all randomized patients
|
62 years
n=4 Participants • Full analysis set - all randomized patients
|
61 years
n=27 Participants • Full analysis set - all randomized patients
|
61 years
n=483 Participants • Full analysis set - all randomized patients
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants • Full analysis set - all randomized patients
|
13 Participants
n=4 Participants • Full analysis set - all randomized patients
|
14 Participants
n=27 Participants • Full analysis set - all randomized patients
|
47 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Sex: Female, Male
Male
|
113 Participants
n=93 Participants • Full analysis set - all randomized patients
|
54 Participants
n=4 Participants • Full analysis set - all randomized patients
|
53 Participants
n=27 Participants • Full analysis set - all randomized patients
|
220 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants • Full analysis set - all randomized patients
|
0 Participants
n=4 Participants • Full analysis set - all randomized patients
|
0 Participants
n=27 Participants • Full analysis set - all randomized patients
|
0 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants • Full analysis set - all randomized patients
|
3 Participants
n=4 Participants • Full analysis set - all randomized patients
|
2 Participants
n=27 Participants • Full analysis set - all randomized patients
|
9 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants • Full analysis set - all randomized patients
|
0 Participants
n=4 Participants • Full analysis set - all randomized patients
|
0 Participants
n=27 Participants • Full analysis set - all randomized patients
|
0 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants • Full analysis set - all randomized patients
|
3 Participants
n=4 Participants • Full analysis set - all randomized patients
|
1 Participants
n=27 Participants • Full analysis set - all randomized patients
|
10 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race (NIH/OMB)
White
|
115 Participants
n=93 Participants • Full analysis set - all randomized patients
|
58 Participants
n=4 Participants • Full analysis set - all randomized patients
|
57 Participants
n=27 Participants • Full analysis set - all randomized patients
|
230 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants • Full analysis set - all randomized patients
|
0 Participants
n=4 Participants • Full analysis set - all randomized patients
|
0 Participants
n=27 Participants • Full analysis set - all randomized patients
|
0 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=93 Participants • Full analysis set - all randomized patients
|
3 Participants
n=4 Participants • Full analysis set - all randomized patients
|
7 Participants
n=27 Participants • Full analysis set - all randomized patients
|
18 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race/Ethnicity, Customized
Ethnic group - Hispanic or Latino
|
8 Participants
n=93 Participants • Full analysis set - all randomized patients
|
2 Participants
n=4 Participants • Full analysis set - all randomized patients
|
5 Participants
n=27 Participants • Full analysis set - all randomized patients
|
15 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race/Ethnicity, Customized
Ethnic group - Not Hispanic or Latino
|
119 Participants
n=93 Participants • Full analysis set - all randomized patients
|
64 Participants
n=4 Participants • Full analysis set - all randomized patients
|
58 Participants
n=27 Participants • Full analysis set - all randomized patients
|
241 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race/Ethnicity, Customized
Ethnic group - Total
|
127 Participants
n=93 Participants • Full analysis set - all randomized patients
|
66 Participants
n=4 Participants • Full analysis set - all randomized patients
|
63 Participants
n=27 Participants • Full analysis set - all randomized patients
|
256 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race/Ethnicity, Customized
Asian ethnic group - Asian (not Chinese/Japanese)
|
3 Participants
n=93 Participants • Full analysis set - all randomized patients
|
2 Participants
n=4 Participants • Full analysis set - all randomized patients
|
1 Participants
n=27 Participants • Full analysis set - all randomized patients
|
6 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race/Ethnicity, Customized
Asian ethnic group - Chinese
|
1 Participants
n=93 Participants • Full analysis set - all randomized patients
|
1 Participants
n=4 Participants • Full analysis set - all randomized patients
|
1 Participants
n=27 Participants • Full analysis set - all randomized patients
|
3 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race/Ethnicity, Customized
Asian ethnic group - Total
|
4 Participants
n=93 Participants • Full analysis set - all randomized patients
|
3 Participants
n=4 Participants • Full analysis set - all randomized patients
|
2 Participants
n=27 Participants • Full analysis set - all randomized patients
|
9 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
2 Participants
n=93 Participants • Full analysis set - all randomized patients
|
0 Participants
n=4 Participants • Full analysis set - all randomized patients
|
2 Participants
n=27 Participants • Full analysis set - all randomized patients
|
4 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Negative PD-L1 status
PD-L1 negative patients
|
133 Participants
n=93 Participants • Full analysis set - all randomized patients
|
67 Participants
n=4 Participants • Full analysis set - all randomized patients
|
67 Participants
n=27 Participants • Full analysis set - all randomized patients
|
267 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
HPV status
Positive
|
39 Participants
n=93 Participants • Full analysis set - all randomized patients
|
18 Participants
n=4 Participants • Full analysis set - all randomized patients
|
18 Participants
n=27 Participants • Full analysis set - all randomized patients
|
75 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
HPV status
Negative
|
94 Participants
n=93 Participants • Full analysis set - all randomized patients
|
49 Participants
n=4 Participants • Full analysis set - all randomized patients
|
49 Participants
n=27 Participants • Full analysis set - all randomized patients
|
192 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Use of nicotine (other than cigarettes)
Yes
|
1 Participants
n=93 Participants • Full analysis set - all randomized patients
|
1 Participants
n=4 Participants • Full analysis set - all randomized patients
|
0 Participants
n=27 Participants • Full analysis set - all randomized patients
|
2 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Use of nicotine (other than cigarettes)
No
|
132 Participants
n=93 Participants • Full analysis set - all randomized patients
|
66 Participants
n=4 Participants • Full analysis set - all randomized patients
|
67 Participants
n=27 Participants • Full analysis set - all randomized patients
|
265 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Smoking/nicotine status by nicotine user
Current smoker >10 pack years
|
22 Participants
n=93 Participants • Full analysis set - all randomized patients
|
7 Participants
n=4 Participants • Full analysis set - all randomized patients
|
6 Participants
n=27 Participants • Full analysis set - all randomized patients
|
35 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Smoking/nicotine status by nicotine user
Current smoker <= 10 pack years
|
2 Participants
n=93 Participants • Full analysis set - all randomized patients
|
0 Participants
n=4 Participants • Full analysis set - all randomized patients
|
1 Participants
n=27 Participants • Full analysis set - all randomized patients
|
3 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Smoking/nicotine status by nicotine user
Former smoker >10 pack years
|
59 Participants
n=93 Participants • Full analysis set - all randomized patients
|
35 Participants
n=4 Participants • Full analysis set - all randomized patients
|
34 Participants
n=27 Participants • Full analysis set - all randomized patients
|
128 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Smoking/nicotine status by nicotine user
Former smoker <= 10 pack years
|
30 Participants
n=93 Participants • Full analysis set - all randomized patients
|
16 Participants
n=4 Participants • Full analysis set - all randomized patients
|
12 Participants
n=27 Participants • Full analysis set - all randomized patients
|
58 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
Smoking/nicotine status by nicotine user
Never
|
20 Participants
n=93 Participants • Full analysis set - all randomized patients
|
9 Participants
n=4 Participants • Full analysis set - all randomized patients
|
14 Participants
n=27 Participants • Full analysis set - all randomized patients
|
43 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
WHO/ECOG performance status at study entry
(0) Normal activity
|
40 Participants
n=93 Participants • Full analysis set - all randomized patients
|
22 Participants
n=4 Participants • Full analysis set - all randomized patients
|
19 Participants
n=27 Participants • Full analysis set - all randomized patients
|
81 Participants
n=483 Participants • Full analysis set - all randomized patients
|
|
WHO/ECOG performance status at study entry
(1) Restricted activity
|
93 Participants
n=93 Participants • Full analysis set - all randomized patients
|
45 Participants
n=4 Participants • Full analysis set - all randomized patients
|
48 Participants
n=27 Participants • Full analysis set - all randomized patients
|
186 Participants
n=483 Participants • Full analysis set - all randomized patients
|
PRIMARY outcome
Timeframe: After 6 monthsPopulation: Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease
Objective response rate, primary analysis, based on BICR assessments according to RECIST v1.1. The number (%) of patients with a response excludes unconfirmed responses
Outcome measures
| Measure |
MEDI4736 + Tremelimumab
n=130 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=65 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=63 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
Total across all treatment groups
|
|---|---|---|---|---|
|
Objective Response Rate at 6 Months
|
7.7 % participants
Interval 3.75 to 13.69
|
9.2 % participants
Interval 3.46 to 19.02
|
1.6 % participants
Interval 0.04 to 8.53
|
—
|
PRIMARY outcome
Timeframe: After 12 monthsPopulation: Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease
Objective response rate (per RECIST 1.1 as assessed by blinded independent central review \[BICR\]) is defined as the number (%) of patients with a confirmed complete response or confirmed partial response and will be based on all treated patients who are PD-L1-positive with measurable disease at baseline per BICR. Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1. criteria are: Complete response \[CR\] = disappearance of all target lesions since baseline; and partial response \[PR\] = at least a 30% decrease in the sum of the diameters of target lesions.
Outcome measures
| Measure |
MEDI4736 + Tremelimumab
n=129 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=65 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=63 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
Total across all treatment groups
|
|---|---|---|---|---|
|
Objective Response Rate at 12 Months
Overall
|
7.8 % participants
Interval 3.78 to 13.79
|
9.2 % participants
Interval 3.46 to 19.02
|
1.6 % participants
Interval 0.04 to 8.53
|
—
|
|
Objective Response Rate at 12 Months
Current smoking/nicotine status - Total
|
13.6 % participants
Interval 2.91 to 34.91
|
14.3 % participants
Interval 0.36 to 57.87
|
14.3 % participants
Interval 0.36 to 57.87
|
—
|
|
Objective Response Rate at 12 Months
Current smoking/nicotine status - >10 pack years
|
15.0 % participants
Interval 3.21 to 37.89
|
14.3 % participants
Interval 0.36 to 57.87
|
16.7 % participants
Interval 0.42 to 64.12
|
—
|
|
Objective Response Rate at 12 Months
Current smoking/nicotine status - ≤10 pack years
|
0 % participants
Interval 0.0 to 84.19
|
—
|
0 % participants
Interval 0.0 to 97.5
|
—
|
|
Objective Response Rate at 12 Months
Former smoking/nicotine status -Total
|
6.8 % participants
Interval 2.54 to 14.25
|
8.2 % participants
Interval 2.27 to 19.6
|
0 % participants
Interval 0.0 to 8.04
|
—
|
|
Objective Response Rate at 12 Months
Former smoking/nicotine status - >10 pack years
|
5.2 % participants
Interval 1.08 to 14.38
|
9.1 % participants
Interval 1.92 to 24.33
|
0 % participants
Interval 0.0 to 10.89
|
—
|
|
Objective Response Rate at 12 Months
Former smoking/nicotine status - ≤10 pack years
|
10.0 % participants
Interval 2.11 to 26.53
|
6.3 % participants
Interval 0.16 to 30.23
|
0 % participants
Interval 0.0 to 26.46
|
—
|
|
Objective Response Rate at 12 Months
Smoking/nicotine status - Never
|
5.3 % participants
Interval 0.13 to 26.03
|
11.1 % participants
Interval 0.28 to 48.25
|
0 % participants
Interval 0.0 to 26.46
|
—
|
|
Objective Response Rate at 12 Months
HPV status - Positive
|
5.4 % participants
Interval 0.66 to 18.19
|
16.7 % participants
Interval 3.58 to 41.42
|
0 % participants
Interval 0.0 to 18.53
|
—
|
|
Objective Response Rate at 12 Months
HPV status - Negative
|
8.7 % participants
Interval 3.83 to 16.42
|
6.4 % participants
Interval 1.34 to 17.54
|
2.2 % participants
Interval 0.06 to 11.77
|
—
|
SECONDARY outcome
Timeframe: After 12 monthsPopulation: Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease
The best response a patient has had during their time in the study
Outcome measures
| Measure |
MEDI4736 + Tremelimumab
n=129 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=65 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=63 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
n=257 Participants
Total across all treatment groups
|
|---|---|---|---|---|
|
Best Objective Response
Response - Total
|
7.8 % participants
|
9.2 % participants
|
1.6 % participants
|
6.6 % participants
|
|
Best Objective Response
Response - Complete response (CR)
|
0 % participants
|
0 % participants
|
0 % participants
|
0 % participants
|
|
Best Objective Response
Response - Partial response (PR)
|
7.8 % participants
|
9.2 % participants
|
1.6 % participants
|
6.6 % participants
|
|
Best Objective Response
Non-response (NR) - Total
|
92.2 % participants
|
90.8 % participants
|
98.4 % participants
|
93.4 % participants
|
|
Best Objective Response
NR - Stable disease (SD) >=6 months (24 weeks)
|
5.4 % participants
|
6.2 % participants
|
0 % participants
|
4.3 % participants
|
|
Best Objective Response
NR - Unconfirmed complete or partial response (PR)
|
1.6 % participants
|
0 % participants
|
0 % participants
|
0.8 % participants
|
|
Best Objective Response
NR - Stable disease
|
3.9 % participants
|
6.2 % participants
|
0 % participants
|
3.5 % participants
|
|
Best Objective Response
NR - Progression
|
64.3 % participants
|
64.6 % participants
|
69.8 % participants
|
65.8 % participants
|
|
Best Objective Response
NR - Progression-RECIST 1.1 progression
|
45.7 % participants
|
46.2 % participants
|
54.0 % participants
|
47.9 % participants
|
|
Best Objective Response
NR - Progression-Death
|
18.6 % participants
|
18.5 % participants
|
15.9 % participants
|
17.9 % participants
|
|
Best Objective Response
NR - Not evaluable-Total
|
22.5 % participants
|
20.0 % participants
|
28.6 % participants
|
23.3 % participants
|
|
Best Objective Response
NR - Not evaluable-SD <6 months (24 weeks)
|
20.2 % participants
|
16.9 % participants
|
19.0 % participants
|
19.1 % participants
|
|
Best Objective Response
NR - Not evaluable-Incomplete post baseline tests
|
2.3 % participants
|
3.1 % participants
|
9.5 % participants
|
4.3 % participants
|
SECONDARY outcome
Timeframe: After 12 monthsPopulation: Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease
Participants remaining in response - based on BICR assessments according to RECIST v1.1. An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off.
Outcome measures
| Measure |
MEDI4736 + Tremelimumab
n=10 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=6 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=1 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
n=17 Participants
Total across all treatment groups
|
|---|---|---|---|---|
|
Duration of Response - Participants Remaining in Response
Percentage remaining in response-3 months
|
90.0 % participants
|
100 % participants
|
100 % participants
|
94.1 % participants
|
|
Duration of Response - Participants Remaining in Response
Percentage remaining in response-6 months
|
70.0 % participants
|
66.7 % participants
|
100 % participants
|
70.6 % participants
|
|
Duration of Response - Participants Remaining in Response
Percentage remaining in response-9 months
|
58.3 % participants
|
66.7 % participants
|
NA % participants
No participants in this category
|
64.2 % participants
|
|
Duration of Response - Participants Remaining in Response
Percentage remaining in response-12 months
|
46.7 % participants
|
NA % participants
No participants in this category
|
NA % participants
No participants in this category
|
53.5 % participants
|
|
Duration of Response - Participants Remaining in Response
Percentage of ongoing response
|
50.0 % participants
|
66.7 % participants
|
100 % participants
|
58.8 % participants
|
SECONDARY outcome
Timeframe: After 12 monthsPopulation: Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease
Time to response in patients with objective response based on BICR assessments according to RECIST 1.1
Outcome measures
| Measure |
MEDI4736 + Tremelimumab
n=10 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=6 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=1 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
n=17 Participants
Total across all treatment groups
|
|---|---|---|---|---|
|
Time to Response
Week 17, where response is first observed
|
10.0 % participants
|
16.7 % participants
|
0 % participants
|
11.8 % participants
|
|
Time to Response
Week 25, where response is first observed
|
10.0 % participants
|
16.7 % participants
|
0 % participants
|
11.8 % participants
|
|
Time to Response
Week 20, where response is first observed
|
0 % participants
|
16.7 % participants
|
0 % participants
|
5.9 % participants
|
|
Time to Response
Week 24, where response is first observed
|
10.0 % participants
|
16.7 % participants
|
0 % participants
|
11.8 % participants
|
|
Time to Response
Number of responders
|
100 % participants
|
100 % participants
|
100 % participants
|
100 % participants
|
|
Time to Response
Week 8, where response is first observed
|
10.0 % participants
|
0 % participants
|
0 % participants
|
5.9 % participants
|
|
Time to Response
Week 9, where response is first observed
|
50.0 % participants
|
16.7 % participants
|
100 % participants
|
41.2 % participants
|
|
Time to Response
Week 16, where response is first observed
|
10.0 % participants
|
16.7 % participants
|
0 % participants
|
11.8 % participants
|
SECONDARY outcome
Timeframe: After 12 monthsPopulation: Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease
Time to onset of response in patients with objective response based on BICR assessments according to RECIST 1.1
Outcome measures
| Measure |
MEDI4736 + Tremelimumab
n=10 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=6 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=1 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
n=17 Participants
Total across all treatment groups
|
|---|---|---|---|---|
|
Time to Onset of Response From First Dose
|
2.0 Months
Interval 2.0 to 6.0
|
4.1 Months
Interval 2.0 to 6.0
|
1.8 Months
Interval 1.8 to 2.0
|
3.5 Months
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: After 6 monthsPopulation: Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease
Disease control rate (DCR) at 6 months based on BICR assessments according to RECIST v1.1. DCR at 6 months was evaluated using 2 different approaches to the length of stable disease (SD). -Method 1: Patients who had a best objective response of complete response (CR) or partial response (PR) within 24 weeks or had demonstrated SD for a minimum interval of 24 weeks following randomization. -Method 2: Patients who had a best objective response of CR or PR in the first 24 weeks or who had demonstrated SD for a minimum interval of 16 weeks following randomization.
Outcome measures
| Measure |
MEDI4736 + Tremelimumab
n=129 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=65 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=63 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
n=257 Participants
Total across all treatment groups
|
|---|---|---|---|---|
|
Disease Control Rate (DCR)
METHOD 2: No DC at 6 months
|
79.8 % participants
|
73.8 % participants
|
90.5 % participants
|
80.9 % participants
|
|
Disease Control Rate (DCR)
METHOD 2: No DC at 6 months-Not evaluable/missing
|
20.2 % participants
|
20.0 % participants
|
22.2 % participants
|
20.6 % participants
|
|
Disease Control Rate (DCR)
METHOD 1: Disease control (DC) at 6 months
|
13.2 % participants
|
21.5 % participants
|
1.6 % participants
|
12.5 % participants
|
|
Disease Control Rate (DCR)
METHOD 1: No DC at 6 months
|
86.8 % participants
|
78.5 % participants
|
98.4 % participants
|
87.5 % participants
|
|
Disease Control Rate (DCR)
METHOD 1: No DC at 6 months-Not evaluable/missing
|
20.2 % participants
|
20.0 % participants
|
22.2 % participants
|
20.6 % participants
|
|
Disease Control Rate (DCR)
METHOD 2: DC at 6 months
|
20.2 % participants
|
26.2 % participants
|
9.5 % participants
|
19.1 % participants
|
SECONDARY outcome
Timeframe: After 12 monthsPopulation: Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease
Disease control rate (DCR) at 12 months based on BICR assessments according to RECIST v1.1. DCR at 6 months was evaluated using 2 different approaches to the length of stable disease (SD). -Method 1: Patients who had a best objective response of complete response (CR) or partial response (PR) within 24 weeks or had demonstrated SD for a minimum interval of 24 weeks following randomization. -Method 2: Patients who had a best objective response of CR or PR in the first 24 weeks or who had demonstrated SD for a minimum interval of 16 weeks following randomization.
Outcome measures
| Measure |
MEDI4736 + Tremelimumab
n=129 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=65 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=63 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
n=257 Participants
Total across all treatment groups
|
|---|---|---|---|---|
|
Disease Control Rate (DCR)
DC at 12 months
|
10.1 % participants
|
12.3 % participants
|
1.6 % participants
|
8.6 % participants
|
|
Disease Control Rate (DCR)
No DC at 12 months
|
89.9 % participants
|
87.7 % participants
|
98.4 % participants
|
91.4 % participants
|
|
Disease Control Rate (DCR)
No DC at 12 months-Not evaluable/missing
|
20.2 % participants
|
20.0 % participants
|
22.2 % participants
|
20.6 % participants
|
SECONDARY outcome
Timeframe: After 6 monthsPopulation: Full analysis set - all randomized patients
Progression status at 6 months based on BICR assessments according to RECIST v1.1 at time of Progression Free Survival (PFS) analysis. Progression was defined as the time from the data of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. -Target Lesions, Non Target Lesions and New Lesions are not necessarily mutually exclusive categories. -Progression death refers to death in the absence of RECIST 1.1 progression.
Outcome measures
| Measure |
MEDI4736 + Tremelimumab
n=133 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=67 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=67 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
n=267 Participants
Total across all treatment groups
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
No progression-Withdrawn consent
|
0.8 % participants
|
3.0 % participants
|
1.5 % participants
|
1.5 % participants
|
|
Progression-free Survival (PFS)
Progression-Total
|
82.0 % participants
|
82.1 % participants
|
88.1 % participants
|
83.5 % participants
|
|
Progression-free Survival (PFS)
Total-RECIST 1.1 Progression
|
57.9 % participants
|
59.7 % participants
|
67.2 % participants
|
60.7 % participants
|
|
Progression-free Survival (PFS)
RECIST 1.1 progression-Target Lesions
|
43.6 % participants
|
43.3 % participants
|
55.2 % participants
|
46.4 % participants
|
|
Progression-free Survival (PFS)
RECIST 1.1 progression-Non-target lesions
|
21.1 % participants
|
26.9 % participants
|
32.8 % participants
|
25.5 % participants
|
|
Progression-free Survival (PFS)
RECIST 1.1 progression-New lesions
|
26.3 % participants
|
20.9 % participants
|
26.9 % participants
|
25.1 % participants
|
|
Progression-free Survival (PFS)
Progression-Death
|
24.1 % participants
|
22.4 % participants
|
20.9 % participants
|
22.8 % participants
|
|
Progression-free Survival (PFS)
No progression-Total
|
18.0 % participants
|
17.9 % participants
|
11.9 % participants
|
16.5 % participants
|
|
Progression-free Survival (PFS)
No progression-PD free and still being followed
|
14.3 % participants
|
13.4 % participants
|
4.5 % participants
|
11.6 % participants
|
|
Progression-free Survival (PFS)
No progression-Censored on Study Day 1
|
1.5 % participants
|
0 % participants
|
0 % participants
|
0.7 % participants
|
|
Progression-free Survival (PFS)
No progression- Censored death
|
1.5 % participants
|
1.5 % participants
|
3.0 % participants
|
1.9 % participants
|
|
Progression-free Survival (PFS)
No progression- Discontinued study
|
0 % participants
|
0 % participants
|
3.0 % participants
|
0.7 % participants
|
SECONDARY outcome
Timeframe: After 12 monthsPopulation: Full analysis set - all randomized patients
Progression status at 12 months based on BICR assessments according to RECIST v1.1 at time of Progression Free Survival (PFS) analysis. Progression was defined as the time from the data of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. -Target Lesions, Non Target Lesions and New Lesions are not necessarily mutually exclusive categories. -Progression death refers to death in the absence of RECIST 1.1 progression.
Outcome measures
| Measure |
MEDI4736 + Tremelimumab
n=133 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=67 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=67 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
n=267 Participants
Total across all treatment groups
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
Progression-Total
|
88.7 % participants
|
83.6 % participants
|
89.6 % participants
|
87.6 % participants
|
|
Progression-free Survival (PFS)
Total-RECIST 1.1 Progression
|
64.7 % participants
|
59.7 % participants
|
68.7 % participants
|
64.4 % participants
|
|
Progression-free Survival (PFS)
RECIST 1.1 progression-Target Lesions
|
50.4 % participants
|
47.8 % participants
|
56.7 % participants
|
51.3 % participants
|
|
Progression-free Survival (PFS)
RECIST 1.1 progression-Non-target lesions
|
23.3 % participants
|
28.4 % participants
|
32.8 % participants
|
27.0 % participants
|
|
Progression-free Survival (PFS)
RECIST 1.1 progression-New lesions
|
27.1 % participants
|
23.9 % participants
|
23.9 % participants
|
25.5 % participants
|
|
Progression-free Survival (PFS)
Progression-Death
|
24.1 % participants
|
23.9 % participants
|
20.9 % participants
|
23.2 % participants
|
|
Progression-free Survival (PFS)
No progression-Total
|
11.3 % participants
|
16.4 % participants
|
10.4 % participants
|
12.4 % participants
|
|
Progression-free Survival (PFS)
No progression-PD free and still being followed
|
6.8 % participants
|
11.9 % participants
|
3.0 % participants
|
7.1 % participants
|
|
Progression-free Survival (PFS)
No progression-Censored death
|
3.8 % participants
|
0 % participants
|
3.0 % participants
|
2.6 % participants
|
|
Progression-free Survival (PFS)
No progression-Withdrawn consent
|
0.8 % participants
|
4.5 % participants
|
1.5 % participants
|
1.9 % participants
|
|
Progression-free Survival (PFS)
No progression-Discontinued study
|
0 % participants
|
0 % participants
|
3.0 % participants
|
0.7 % participants
|
SECONDARY outcome
Timeframe: After 12 monthsPopulation: Full analysis set - all randomized patients
Survival status at time of overall survival analysis. 'Still in survival follow-up' includes patients known to be alive at data cut-off. 'Terminated prior to death' includes patients with unknown survival status or patients who were lost to follow-up.
Outcome measures
| Measure |
MEDI4736 + Tremelimumab
n=133 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=67 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=67 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
n=267 Participants
Total across all treatment groups
|
|---|---|---|---|---|
|
Overall Survival
Death
|
64.7 % participants
|
65.7 % participants
|
76.1 % participants
|
67.8 % participants
|
|
Overall Survival
Still in survival follow-up
|
30.1 % participants
|
28.4 % participants
|
16.4 % participants
|
26.2 % participants
|
|
Overall Survival
Terminated prior to death
|
5.3 % participants
|
6.0 % participants
|
7.5 % participants
|
6.0 % participants
|
|
Overall Survival
Terminated prior to death-Voluntary discon.
|
5.3 % participants
|
6.0 % participants
|
4.5 % participants
|
5.2 % participants
|
|
Overall Survival
Terminated prior to death-Other
|
0 % participants
|
0 % participants
|
3.0 % participants
|
0.7 % participants
|
SECONDARY outcome
Timeframe: After 12 monthsPopulation: Full analysis set - all randomized patients
Improvement in quality of life was assessed using European Organisation for Research and Treatment of Cancer (EORTC) questionnaires: -The impact of treatment on Health-Related Quality of Life, functioning, and symptoms was evaluated using the EORTC QLQ-C30 v3. -Head and neck cancer-specific symptoms were evaluated using the EORTC QLQ-H\&N35. The symptom and QoL/function improvement rate was defined as the number (%) of patients with 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (a decrease from baseline score ≥10 or EORTC QLQ-C30 scales) in that symptom/function from baseline. For QLQ-H\&N35A a minimum clinically meaningful change was defined as a change in the score from baseline of \>10 for scales/items
Outcome measures
| Measure |
MEDI4736 + Tremelimumab
n=133 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=67 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=67 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
Total across all treatment groups
|
|---|---|---|---|---|
|
Quality of Life
EORTC QLQ-C30 Function-Physical
|
12 % patients
Interval 6.7 to 20.8
|
13.6 % patients
Interval 6.4 to 26.7
|
5.1 % patients
Interval 1.4 to 16.9
|
—
|
|
Quality of Life
EORTC QLQ-C30 Function-Role
|
16.3 % patients
Interval 10.0 to 25.5
|
16.7 % patients
Interval 8.3 to 30.6
|
11.8 % patients
Interval 4.7 to 26.6
|
—
|
|
Quality of Life
EORTC QLQ-C30 Function-Cognitive
|
25 % patients
Interval 16.2 to 36.4
|
29.4 % patients
Interval 16.8 to 46.2
|
10.7 % patients
Interval 3.7 to 27.2
|
—
|
|
Quality of Life
EORTC QLQ-C30 Function-Emotional
|
13.5 % patients
Interval 7.9 to 22.1
|
13.6 % patients
Interval 6.4 to 26.7
|
2.6 % patients
Interval 0.5 to 13.2
|
—
|
|
Quality of Life
EORTC QLQ-C30 Function-Social
|
18.3 % patients
Interval 11.0 to 28.8
|
15.2 % patients
Interval 6.7 to 30.9
|
16.1 % patients
Interval 7.1 to 32.6
|
—
|
|
Quality of Life
EORTC QLQ-C30 Symptom-Fatigue
|
16.8 % patients
Interval 10.9 to 25.0
|
17.3 % patients
Interval 9.4 to 29.7
|
7.5 % patients
Interval 3.0 to 17.9
|
—
|
|
Quality of Life
EORTC QLQ-C30 Symptom-Pain
|
22.8 % patients
Interval 15.4 to 32.4
|
20.8 % patients
Interval 11.7 to 34.3
|
6.7 % patients
Interval 2.3 to 17.9
|
—
|
|
Quality of Life
EORTC QLQ-C30 Symptom-Nausea/vomiting
|
22.2 % patients
Interval 12.5 to 36.3
|
16.7 % patients
Interval 4.7 to 44.8
|
17.6 % patients
Interval 6.2 to 41.0
|
—
|
|
Quality of Life
EORTC QLQ-C30 Global health status/QoL
|
13.4 % patients
Interval 8.3 to 20.9
|
7.3 % patients
Interval 2.9 to 17.3
|
3.7 % patients
Interval 1.0 to 12.5
|
—
|
|
Quality of Life
EORTC QLQ-H&N35 Scale-Pain
|
16.7 % patients
Interval 9.8 to 26.9
|
19.4 % patients
Interval 9.8 to 35.0
|
8.3 % patients
Interval 2.9 to 21.8
|
—
|
|
Quality of Life
EORTC QLQ-H&N35 Scale-Swallowing
|
16.0 % patients
Interval 9.4 to 25.9
|
13.3 % patients
Interval 6.3 to 26.2
|
10.3 % patients
Interval 4.1 to 23.6
|
—
|
|
Quality of Life
EORTC QLQ-H&N35 Scale-Senses
|
17.8 % patients
Interval 10.7 to 28.1
|
24.3 % patients
Interval 13.4 to 40.1
|
23.1 % patients
Interval 12.6 to 38.3
|
—
|
|
Quality of Life
EORTC QLQ-H&N35 Scale-Speech
|
20.2 % patients
Interval 13.3 to 29.4
|
9.8 % patients
Interval 4.3 to 21.0
|
19.6 % patients
Interval 10.7 to 33.2
|
—
|
|
Quality of Life
EORTC QLQ-H&N35 Scale-Social eating
|
21.3 % patients
Interval 13.7 to 31.4
|
20.0 % patients
Interval 10.9 to 33.8
|
15.0 % patients
Interval 7.1 to 29.1
|
—
|
|
Quality of Life
EORTC QLQ-H&N35 Scale-Social contact
|
22.6 % patients
Interval 14.0 to 34.4
|
5.9 % patients
Interval 1.6 to 19.1
|
13.0 % patients
Interval 4.5 to 32.1
|
—
|
|
Quality of Life
EORTC QLQ-H&N35 Scale-Sexuality
|
16.2 % patients
Interval 9.5 to 26.2
|
9.5 % patients
Interval 3.8 to 22.1
|
9.5 % patients
Interval 3.8 to 22.1
|
—
|
SECONDARY outcome
Timeframe: After 12 monthsPopulation: Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease
Duration of objective response in patients with objective response based on BICR assessments according to RECIST v1.1. Duration of response was the time from the first documentation of Complete response/Partial response (which was subsequently confirmed) until the date of progression, death, or the last evaluable RECIST assessment for patients that did not progress. An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off (per RECIST v1.1 as assessed by BICR).
Outcome measures
| Measure |
MEDI4736 + Tremelimumab
n=10 Participants
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=6 Participants
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=1 Participants
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
Total
n=17 Participants
Total across all treatment groups
|
|---|---|---|---|---|
|
Duration of Response
No. progressed or died within 12 months
|
5 Participants
|
2 Participants
|
0 Participants
|
7 Participants
|
|
Duration of Response
No. progressed or died after 12 months
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
MEDI4736 AND TREMELIMUMAB COMBINATION
Serious events: 59 serious events
Other events: 110 other events
Deaths: 86 deaths
MEDI4736
Serious events: 18 serious events
Other events: 52 other events
Deaths: 44 deaths
Tremelimumab
Serious events: 25 serious events
Other events: 59 other events
Deaths: 51 deaths
Serious adverse events
| Measure |
MEDI4736 AND TREMELIMUMAB COMBINATION
n=133 participants at risk
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=65 participants at risk
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=65 participants at risk
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
2/133 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Cardiac disorders
Angina pectoris
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Cardiac disorders
Bradycardia
|
0.75%
1/133 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Cardiac disorders
Cardiac arrest
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Cardiac disorders
Sinus tachycardia
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Endocrine disorders
Hypothyroidism
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Endocrine disorders
Lymphocytic hypophysitis
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Colitis
|
1.5%
2/133 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
5/133 • Number of events 8 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 7 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
3.1%
2/65 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
3/133 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Oral cavity fistula
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.5%
2/133 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
2/133 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
General disorders
Asthenia
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
General disorders
Death
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
General disorders
Face oedema
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
General disorders
Fatigue
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
General disorders
General physical health deterioration
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
General disorders
Pain
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
General disorders
Pyrexia
|
2.3%
3/133 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Hepatobiliary disorders
Hepatitis
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Abdominal infection
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Abscess
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Bacteraemia
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Bronchitis
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Device related sepsis
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Localised infection
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Lung infection
|
3.0%
4/133 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Mastoiditis
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Pneumonia
|
6.8%
9/133 • Number of events 10 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
3.1%
2/65 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Sepsis
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Septic rash
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Superinfection
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Investigations
Platelet count decreased
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Investigations
Weight decreased
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.3%
3/133 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
4/133 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.0%
4/133 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.5%
2/133 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.5%
2/133 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
3.1%
2/65 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Nervous system disorders
Ischaemic stroke
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Nervous system disorders
Presyncope
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Nervous system disorders
Syncope
|
0.75%
1/133 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Product Issues
Device dislocation
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Psychiatric disorders
Agitation
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Psychiatric disorders
Confusional state
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Psychiatric disorders
Delirium
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Renal and urinary disorders
Urinary retention
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
4/133 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
3.1%
2/65 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.5%
2/133 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.3%
3/133 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
3.1%
2/65 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
2/133 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/133 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Vascular disorders
Exsanguination
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Vascular disorders
Hypotension
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Vascular disorders
Orthostatic hypotension
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
Other adverse events
| Measure |
MEDI4736 AND TREMELIMUMAB COMBINATION
n=133 participants at risk
MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
|
MEDI4736
n=65 participants at risk
MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
|
Tremelimumab
n=65 participants at risk
Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.0%
20/133 • Number of events 20 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
16.9%
11/65 • Number of events 14 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
16.9%
11/65 • Number of events 12 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Cardiac disorders
Tachycardia
|
3.8%
5/133 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
6.2%
4/65 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Ear and labyrinth disorders
Ear pain
|
2.3%
3/133 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
3.1%
2/65 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
6.2%
4/65 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Endocrine disorders
Hypothyroidism
|
11.3%
15/133 • Number of events 15 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
13.8%
9/65 • Number of events 9 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
9.2%
6/65 • Number of events 6 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Constipation
|
13.5%
18/133 • Number of events 19 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
13.8%
9/65 • Number of events 9 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
12.3%
8/65 • Number of events 8 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.3%
27/133 • Number of events 42 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
18.5%
12/65 • Number of events 14 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
21.5%
14/65 • Number of events 19 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Dysphagia
|
10.5%
14/133 • Number of events 15 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
12.3%
8/65 • Number of events 9 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
9.2%
6/65 • Number of events 7 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
13.5%
18/133 • Number of events 24 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
10.8%
7/65 • Number of events 8 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
27.7%
18/65 • Number of events 22 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
9/133 • Number of events 13 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
6.2%
4/65 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
13.8%
9/65 • Number of events 11 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
General disorders
Asthenia
|
15.8%
21/133 • Number of events 24 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
15.4%
10/65 • Number of events 12 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
12.3%
8/65 • Number of events 11 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
General disorders
Fatigue
|
18.8%
25/133 • Number of events 29 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
29.2%
19/65 • Number of events 23 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
18.5%
12/65 • Number of events 12 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
General disorders
Mucosal inflammation
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
6.2%
4/65 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
General disorders
Oedema peripheral
|
5.3%
7/133 • Number of events 7 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
3.1%
2/65 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
3.1%
2/65 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
General disorders
Pain
|
3.8%
5/133 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
12.3%
8/65 • Number of events 8 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
General disorders
Pyrexia
|
12.0%
16/133 • Number of events 19 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
18.5%
12/65 • Number of events 16 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Investigations
Weight decreased
|
13.5%
18/133 • Number of events 18 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
12.3%
8/65 • Number of events 9 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.8%
25/133 • Number of events 27 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
15.4%
10/65 • Number of events 11 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
15.4%
10/65 • Number of events 11 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
6/133 • Number of events 10 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
9.2%
6/65 • Number of events 6 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.3%
7/133 • Number of events 8 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
9.2%
6/65 • Number of events 7 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
4.6%
3/65 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.5%
2/133 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
6.2%
4/65 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
3.1%
2/65 • Number of events 2 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.5%
2/133 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
6.2%
4/65 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
7/133 • Number of events 10 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
4.6%
3/65 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.8%
5/133 • Number of events 6 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.5%
10/133 • Number of events 10 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
6.2%
4/65 • Number of events 6 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
13/133 • Number of events 13 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
4.6%
3/65 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
9/133 • Number of events 10 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.0%
4/133 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 6 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.0%
4/133 • Number of events 8 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
6.2%
4/65 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
9.2%
6/65 • Number of events 8 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Nervous system disorders
Dizziness
|
3.0%
4/133 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
4.6%
3/65 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 6 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
4.5%
6/133 • Number of events 7 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
9.2%
6/65 • Number of events 7 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
10.8%
7/65 • Number of events 7 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Nervous system disorders
Paraesthesia
|
2.3%
3/133 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Psychiatric disorders
Anxiety
|
0.75%
1/133 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
4.6%
3/65 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
6.2%
4/65 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Psychiatric disorders
Insomnia
|
6.8%
9/133 • Number of events 9 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
4.6%
3/65 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
3.1%
2/65 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
14/133 • Number of events 14 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
12.3%
8/65 • Number of events 8 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
10.8%
7/65 • Number of events 8 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
14/133 • Number of events 16 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
15.4%
10/65 • Number of events 10 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
18.5%
12/65 • Number of events 12 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.0%
4/133 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
9.2%
6/65 • Number of events 6 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 6 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.8%
5/133 • Number of events 6 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
14/133 • Number of events 15 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
9.2%
6/65 • Number of events 6 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
6.2%
4/65 • Number of events 4 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.5%
10/133 • Number of events 11 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
4.6%
3/65 • Number of events 3 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 6 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Vascular disorders
Hypertension
|
6.0%
8/133 • Number of events 11 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
9.2%
6/65 • Number of events 7 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
1.5%
1/65 • Number of events 1 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
|
Vascular disorders
Hypotension
|
5.3%
7/133 • Number of events 7 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
0.00%
0/65 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
7.7%
5/65 • Number of events 5 • AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.
AEs were either spontaneously reported by the patient or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. AEs/SAEs were followed up for resolution after discontinuation or study completion and for as long as medically indicated. AE and SAE data are reported using the Safety Analysis Set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review publications prior to public release for a period up to 120 days to confirm accuracy, prevent disclosure of confidential information, and ensure that information is handled appropriately.
- Publication restrictions are in place
Restriction type: OTHER