Trial Outcomes & Findings for A Phase 1 Study of AMG 211 in Participants With Advanced Gastrointestinal Cancer (NCT NCT02291614)
NCT ID: NCT02291614
Last Updated: 2021-03-16
Results Overview
A DLT was defined as any of the following occurring during the first 28 days of treatment and regarded by the investigator and/or sponsor as related to AMG 211. Hematological DLTs: absolute neutrophil count (ANC) \< 0.5 × 10⁹ cells/L for ≥ 7 days; febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection) with ANC \< 0.5 × 10⁹ cells/L and fever ≥ 38.5°C; platelets \< 25 × 10⁹ cells/L ≥ 7 days. Non-hematological DLTs: any AMG 211-related ≥ grade 3 non-hematological toxicity, excluding nausea and vomiting not refractory to anti-emetics, flare-up of pain due to potential increase in tumor volume, cytokine release syndrome manageable with symptomatic treatment and/or infusion interruption of up to 2 days. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 was used to assess toxicities/adverse events.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
28 days
Results posted on
2021-03-16
Participant Flow
This study was conducted at 5 centers in the Netherlands and Germany. Participants were enrolled from 27 November 2014 to 28 March 2017.
This study was to be conducted in 2 parts: dose-escalation and dose-expansion (planned to enroll additional participants to gain further clinical experience with AMG 211). The dose expansion part was not conducted (study terminated early). In the dose-escalation cohorts, participants were assigned sequentially into cohorts as they opened.
Participant milestones
| Measure |
AMG 211 200 µg/Day for 7/14 Days
In cycle 1 participants received 200 µg/day AMG 211 administered as a continuous intravenous (cIV) infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
5
|
3
|
3
|
6
|
3
|
3
|
11
|
2
|
|
Overall Study
Received AMG 211
|
3
|
3
|
3
|
5
|
3
|
3
|
6
|
3
|
3
|
10
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
2
|
4
|
2
|
2
|
5
|
2
|
3
|
9
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
AMG 211 200 µg/Day for 7/14 Days
In cycle 1 participants received 200 µg/day AMG 211 administered as a continuous intravenous (cIV) infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
|
Overall Study
Decision by sponsor
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 1 Study of AMG 211 in Participants With Advanced Gastrointestinal Cancer
Baseline characteristics by cohort
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=6 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
n=3 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
n=3 Participants
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
n=10 Participants
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
n=2 Participants
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
66.0 years
STANDARD_DEVIATION 11.5 • n=107 Participants
|
56.7 years
STANDARD_DEVIATION 12.0 • n=206 Participants
|
60.6 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 8.1 • n=31 Participants
|
64.0 years
STANDARD_DEVIATION 4.6 • n=30 Participants
|
64.5 years
STANDARD_DEVIATION 11.1 • n=3 Participants
|
67.3 years
STANDARD_DEVIATION 7.6 • n=6 Participants
|
66.0 years
STANDARD_DEVIATION 13.1 • n=114 Participants
|
62.2 years
STANDARD_DEVIATION 9.7
|
66.0 years
STANDARD_DEVIATION 4.2 • n=19 Participants
|
63.3 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
3 Participants
|
1 Participants
n=19 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
7 Participants
|
1 Participants
n=19 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
10 Participants
|
2 Participants
n=19 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
|
Race
Black (or African American)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
9 Participants
|
2 Participants
n=19 Participants
|
42 Participants
n=4 Participants
|
|
Race
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Safety Analysis Set: all participants who enrolled and received at least one dose of AMG 211. Participants were evaluable for a DLT if they received at least 90% of planned doses in the first treatment cycle.
A DLT was defined as any of the following occurring during the first 28 days of treatment and regarded by the investigator and/or sponsor as related to AMG 211. Hematological DLTs: absolute neutrophil count (ANC) \< 0.5 × 10⁹ cells/L for ≥ 7 days; febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection) with ANC \< 0.5 × 10⁹ cells/L and fever ≥ 38.5°C; platelets \< 25 × 10⁹ cells/L ≥ 7 days. Non-hematological DLTs: any AMG 211-related ≥ grade 3 non-hematological toxicity, excluding nausea and vomiting not refractory to anti-emetics, flare-up of pain due to potential increase in tumor volume, cytokine release syndrome manageable with symptomatic treatment and/or infusion interruption of up to 2 days. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 was used to assess toxicities/adverse events.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=6 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
n=3 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
n=3 Participants
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
n=10 Participants
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
n=2 Participants
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).Population: Safety Analysis Set: all participants who enrolled and received at least one dose of AMG 211.
An adverse event (AE) was defined as any untoward medical occurrence, which does not necessarily have a causal relationship with study treatment. A serious adverse event (SAE) was defined as an event that: was fatal or life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/borth defect; or other significant medical event. A TEAE was defined as any AE starting on or after the first dose of study drug and up to and including 30 days after the end of last dose of study drug. The severity of each adverse event was graded using CTCAE version 4.03 criteria (1=mild, 2=moderate, 3=severe, 4=life-threatining, 5=death). 'Any TEAE' includes both serious and non-serious TEAEs.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=6 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
n=3 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
n=3 Participants
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
n=10 Participants
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
n=2 Participants
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Grade ≥ 2 TEAE
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
10 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Grade ≥ 4 TEAE
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Serious TEAE (STEAE)
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
9 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE leading to discontinuation of AMG 211
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
STEAE leading to discontinuation of AMG 211
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Non-STEAE leading to discontinuation of AMG 211
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Life-threatening TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Fatal TEAE
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Grade ≥ 3 TEAE
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 (for 14-day dosing groups only) hours after the start of infusion, at the end of infusion (Day 8 or Day 15), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.Population: Participants who received 7- or 14-day dosing.
Levels of AMG 211 in plasma samples collected during this study were analyzed using an electrochemiluminiscence assay. The lower limit of quantification (LLOQ) of the assay was 0.10 ng/mL.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=6 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=3 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of AMG 211 in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days
|
5.32 ng/mL
Standard Deviation 2.26 • Interval 2.26 to
|
11.5 ng/mL
Standard Deviation 7.21 • Interval 7.21 to
|
13.9 ng/mL
Standard Deviation 1.13 • Interval 1.13 to
|
19.8 ng/mL
Standard Deviation 3.67 • Interval 3.67 to
|
55.1 ng/mL
Standard Deviation 11.0 • Interval 11.0 to
|
116 ng/mL
Standard Deviation 32.4 • Interval 32.4 to
|
129 ng/mL
Standard Deviation 51.0 • Interval 51.0 to
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.Population: Participants who received 28-day dosing.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=10 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=2 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of AMG 211 in Cycle 1 in Participants Who Received Dosing for 28 Days
|
45.4 ng/mL
Standard Deviation 8.86 • Interval 8.86 to
|
150 ng/mL
Standard Deviation 68.6 • Interval 68.6 to
|
145 ng/mL
Standard Deviation 45.0 • Interval 45.0 to
|
398 ng/mL
Standard Deviation 99999 • Interval 99999.0 to
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 (for 14-day dosing groups only) hours after the start of infusion, at the end of infusion (Day 8 or Day 15), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.Population: Participants who received 7- or 14-day dosing.
Area under the serum concentration-time curve (AUC) from time 0 to the last quantifiable concentration was estimated using the linear trapezoidal method.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=6 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=3 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days
|
29.7 day*ng/mL
Standard Deviation 19.4 • Interval 19.4 to
|
138 day*ng/mL
Standard Deviation 84.7 • Interval 84.7 to
|
172 day*ng/mL
Standard Deviation 23.0 • Interval 23.0 to
|
214 day*ng/mL
Standard Deviation 77.5 • Interval 77.5 to
|
617 day*ng/mL
Standard Deviation 186 • Interval 186.0 to
|
1540 day*ng/mL
Standard Deviation 936 • Interval 936.0 to
|
1420 day*ng/mL
Standard Deviation 666 • Interval 666.0 to
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.Population: Participants who received 28-day dosing.
Area under the serum concentration-time curve (AUC) from time 0 to the last quantifiable concentration was estimated using the linear trapezoidal method.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=10 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=2 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration in Cycle 1 in Participants Who Received Dosing for 28 Days
|
1040 day*ng/mL
Standard Deviation 245 • Interval 245.0 to
|
3250 day*ng/mL
Standard Deviation 1700 • Interval 1700.0 to
|
2610 day*ng/mL
Standard Deviation 1940 • Interval 1940.0 to
|
6080 day*ng/mL
Standard Deviation 99999 • Interval 99999.0 to
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 (for 14-day dosing groups only) hours after the start of infusion, at the end of infusion (Day 8 or Day 15), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.Population: Participants who received 7- or 14-day dosing.
Area under the serum concentration-time curve from time 0 to infinity was estimated using the linear trapezoidal method
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=6 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=3 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUCinf) in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days
|
30.0 day*ng/mL
Standard Deviation 19.3 • Interval 19.3 to
|
140 day*ng/mL
Standard Deviation 85.6 • Interval 85.6 to
|
173 day*ng/mL
Standard Deviation 23.4 • Interval 23.4 to
|
215 day*ng/mL
Standard Deviation 77.5 • Interval 77.5 to
|
619 day*ng/mL
Standard Deviation 186 • Interval 186.0 to
|
1540 day*ng/mL
Standard Deviation 938 • Interval 938.0 to
|
1430 day*ng/mL
Standard Deviation 673 • Interval 673.0 to
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.Population: Participants who received 28-day dosing.
Area under the serum concentration-time curve from time 0 to infinity was estimated using the linear trapezoidal method
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=7 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=1 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUCinf) in Cycle 1 in Participants Who Received Dosing for 28 Days
|
1040 day*ng/mL
Standard Deviation 245 • Interval 245.0 to
|
3260 day*ng/mL
Standard Deviation 1710 • Interval 1710.0 to
|
3180 day*ng/mL
Standard Deviation 2070 • Interval 2070.0 to
|
6530 day*ng/mL
Standard Deviation 99999 • Interval 99999.0 to
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 (for 14-day dosing groups only) hours after the start of infusion, at the end of infusion (Day 8 or Day 15), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.Population: Participants who received 7- or 14-day dosing.
Terminal half-life (t1/2,z) calculated as t1/2,z = ln(2)/λz, where λz was the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=6 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=3 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-life (T1/2) of AMG-211 in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days
|
10.4 hours
Standard Deviation 3.34 • Interval 3.34 to
|
10.3 hours
Standard Deviation 0.703 • Interval 0.703 to
|
10.2 hours
Standard Deviation 4.37 • Interval 4.37 to
|
7.25 hours
Standard Deviation 2.63 • Interval 2.63 to
|
7.78 hours
Standard Deviation 2.37 • Interval 2.37 to
|
10.3 hours
Standard Deviation 1.72 • Interval 1.72 to
|
11.9 hours
Standard Deviation 3.53 • Interval 3.53 to
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.Population: Participants who received 28-day dosing.
Terminal half-life (t1/2,z) calculated as t1/2,z = ln(2)/λz, where λz was the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=7 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=1 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-life of AMG-211 in Cycle 1 in Participants Who Received Dosing for 28 Days
|
11.1 hours
Standard Deviation 3.45 • Interval 3.45 to
|
6.48 hours
Standard Deviation 5.16 • Interval 5.16 to
|
8.81 hours
Standard Deviation 4.58 • Interval 4.58 to
|
15.2 hours
Standard Deviation 99999 • Interval 99999.0 to
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 (for 14-day dosing groups only) hours after the start of infusion, at the end of infusion (Day 8 or Day 15), and 0.5, 2, 4, 8, and 24 hours after the end of infusionPopulation: Participants who received 7- or 14-day dosing.
Css was calculated as the average concentration between achievement of plateau and the end of infusion.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=6 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=3 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Concentration of AMG 211 at Steady State (Css) in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days
|
4.32 ng/mL
Standard Deviation 3.27 • Interval 3.27 to
|
9.92 ng/mL
Standard Deviation 6.05 • Interval 6.05 to
|
12.4 ng/mL
Standard Deviation 1.73 • Interval 1.73 to
|
16.6 ng/mL
Standard Deviation 4.42 • Interval 4.42 to
|
45.3 ng/mL
Standard Deviation 12.9 • Interval 12.9 to
|
88.0 ng/mL
Standard Deviation 26.4 • Interval 26.4 to
|
96.9 ng/mL
Standard Deviation 50.8 • Interval 50.8 to
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.Population: Participants who received 28-day dosing.
Css was calculated as the average concentration between achievement of plateau and the end of infusion.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=10 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=2 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Concentration of AMG 211 at Steady State (Css) in Cycle 1 in Participants Who Received Dosing for 28 Days
|
35.9 ng/mL
Standard Deviation 7.50 • Interval 7.5 to
|
130 ng/mL
Standard Deviation 63.9 • Interval 63.9 to
|
109 ng/mL
Standard Deviation 36.1 • Interval 36.1 to
|
306 ng/mL
Standard Deviation 99999 • Interval 99999.0 to
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 (for 14-day dosing groups only) hours after the start of infusion, at the end of infusion (Day 8 or Day 15), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.Population: Participants who received 7- or 14-day dosing.
Serum clearance (CL) calculated as CL = (actual dose)/(serum concentrations at steady-state \[Css\] x 24).
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=6 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=3 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Clearance of AMG 211 in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days
|
2.93 L/hr
Standard Deviation 2.18 • Interval 2.18 to
|
1.36 L/hr
Standard Deviation 1.28 • Interval 1.28 to
|
1.36 L/hr
Standard Deviation 0.175 • Interval 0.175 to
|
2.13 L/hr
Standard Deviation 0.609 • Interval 0.609 to
|
1.57 L/hr
Standard Deviation 0.519 • Interval 0.519 to
|
1.62 L/hr
Standard Deviation 0.446 • Interval 0.446 to
|
3.21 L/hr
Standard Deviation 1.31 • Interval 1.31 to
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.Population: Participants who received 28-day dosing.
Serum clearance (CL) calculated as CL = (actual dose)/(serum concentrations at steady-state \[Css\] x 24).
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=10 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=2 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Clearance of AMG 211 in Cycle 1 in Participants Who Received Dosing for 28 Days
|
1.91 L/hr
Standard Deviation 0.412 • Interval 0.412 to
|
1.17 L/hr
Standard Deviation 0.450 • Interval 0.45 to
|
2.66 L/hr
Standard Deviation 0.752 • Interval 0.752 to
|
1.75 L/hr
Standard Deviation 99999 • Interval 99999.0 to
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 (for 14-day dosing groups only) hours after the start of infusion, at the end of infusion (Day 8 or Day 15), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.Population: Participants who received 7- or 14-day dosing.
Volume of distribution at steady-state calculated as (CL x t1/2,z)/0.693.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=6 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=3 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady-state (Vss) in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days
|
50.8 liters
Standard Deviation 50.6 • Interval 50.6 to
|
20.2 liters
Standard Deviation 18.8 • Interval 18.8 to
|
19.2 liters
Standard Deviation 6.11 • Interval 6.11 to
|
22.4 liters
Standard Deviation 10.8 • Interval 10.8 to
|
18.5 liters
Standard Deviation 11.4 • Interval 11.4 to
|
23.5 liters
Standard Deviation 5.12 • Interval 5.12 to
|
50.9 liters
Standard Deviation 13.5 • Interval 13.5 to
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.Population: Participants who received 28-day dosing.
Volume of distribution at steady-state calculated as (CL x t1/2,z)/0.693.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=7 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=1 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady-state (Vss) in Cycle 1 in Participants Who Received Dosing for 28 Days
|
31.3 liters
Standard Deviation 15.0 • Interval 15.0 to
|
11.8 liters
Standard Deviation 12.4 • Interval 12.4 to
|
33.4 liters
Standard Deviation 23.5 • Interval 23.5 to
|
40.3 liters
Standard Deviation 99999 • Interval 99999.0 to
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 24 hours after the end of infusion during each treatment cycle, until 4 weeks after the last dose. Median time frame was 75.5 days.Population: Safety Analysis Set: all participants who enrolled and received at least one dose of AMG 211. Participants with a negative or no result for anti-AMG 211 antibodies at baseline.
Blood samples collected during the study were tested for anti-AMG 211 binding antibodies using an electrochemiluminescence-based bridging immunoassay. The number of participants with anti-AMG 211 antibody formation includes participants with a negative or no result at baseline and a positive antibody binding result postbaseline.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=6 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
n=3 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
n=3 Participants
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
n=10 Participants
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
n=2 Participants
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-AMG 211 Antibody Formation
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Disease response was assessed every second cycle (8-10 weeks) until 4 weeks after the last dose. The median time frame was 75.5 days.Population: Safety Analysis Set: all participants who enrolled and received at least one dose of AMG 211.
Disease response was assessed by radiological imaging using standardized contrast-enhanced magnetic imaging (MRI) or computed tomography (CT), and evaluated according to the modified Immune-Related Response Criteria (irRC). Overall objective response was defined as a best response of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), confirmed by a repeat, consecutive assessment no less than 4 weeks from the date of the first documented assessment. irCR: Complete disappearance of all lesions and no new lesions. irPR: Decrease in tumor burden ≥ 50% relative to baseline.
Outcome measures
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 Participants
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 Participants
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 Participants
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 Participants
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=3 Participants
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=6 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
n=3 Participants
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
n=3 Participants
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
n=10 Participants
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
n=2 Participants
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With an Overall Objective Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Disease response was assessed every second cycle (8-10 weeks) until 4 weeks after the last dose. The median time frame was 75.5 days.Population: No participant had an objective response.
Duration of response was defined as the number of days between the date of the first tumor assessment indicating an objective response through to the subsequent date of progression as classified by modified irRC or death due to any cause. Analyzed in participants with an overall objective response. Overall objective response was defined as a best response of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), confirmed by a repeat, consecutive assessment no less than 4 weeks from the date of the first documented assessment. irCR: Complete disappearance of all lesions and no new lesions. irPR: Decrease in tumor burden ≥ 50% relative to baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Disease response was assessed every second cycle (8-10 weeks) until 4 weeks after the last dose. The median time frame was 75.5 days.Population: No participant had an objective response.
Time to response was defined as the number of days from the first administration of AMG 211 to the first objective assessment of response as per modified irRC. Analyzed in participants with an overall objective response. Overall objective response was defined as a best response of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), confirmed by a repeat, consecutive assessment no less than 4 weeks from the date of the first documented assessment. irCR: Complete disappearance of all lesions and no new lesions. irPR: Decrease in tumor burden ≥ 50% relative to baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of AMG 211 until tumor progression, assessed through the end of study (up to 4 weeks after the last dose). The median time frame was 75.5 days.Population: Per protocol, only participants treated at the MTD were to be included for this analysis. Because the MTD was not determined in this early-terminated study, this analysis could not be performed.
Disease was assessed by radiological imaging using standardized contrast-enhanced MRI or CT, and evaluated according to the modified irRC. Immune-related progressed disease (irPD) was defined as an increase in tumor burden ≥ 25% relative to nadir (minimum recorded tumor burden), confirmed by a repeat, consecutive assessment no less than 4 weeks from the date of the first documented assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Per protocol, only participants treated at the MTD for 6 months were to be included for this analysis. Because the MTD was not determined in this early-terminated study, this analysis could not be performed.
PFS was defined as the percentage of participants who were progression-free at 6 months. Immune-related progressed disease (irPD) was defined as an increase in tumor burden ≥ 25% relative to nadir (minimum recorded tumor burden), confirmed by a repeat, consecutive assessment no less than 4 weeks from the date of the first documented assessment.
Outcome measures
Outcome data not reported
Adverse Events
AMG 211 200 µg/Day for 7/14 Days
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
AMG 211 200 µg/Day for 14 Days
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
AMG 211 400 µg/Day for 14 Days
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
AMG 211 800 µg/Day for 14 Days
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
AMG 211 1600 µg/Day for 14 Days
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
AMG 211 1600 µg/Day for 28 Days
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
AMG 211 3200 µg/Day for 14 Days
Serious events: 6 serious events
Other events: 6 other events
Deaths: 1 deaths
AMG 211 3200 µg/Day for 28 Days
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
AMG 211 6400 µg/Day for 14 Days
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
AMG 211 6400 µg/Day for 28 Days
Serious events: 9 serious events
Other events: 9 other events
Deaths: 1 deaths
AMG 211 12,800 µg/Day for 28 Days
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 participants at risk
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 participants at risk
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 participants at risk
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 participants at risk
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 participants at risk
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=3 participants at risk
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=6 participants at risk
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
n=3 participants at risk
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
n=3 participants at risk
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
n=10 participants at risk
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
n=2 participants at risk
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
2/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Discomfort
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
2/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic infarction
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood calcium increased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram QT shortened
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal stenosis
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Product Issues
Device dislocation
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Product Issues
Device infusion issue
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
AMG 211 200 µg/Day for 7/14 Days
n=3 participants at risk
In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 200 µg/Day for 14 Days
n=3 participants at risk
Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 400 µg/Day for 14 Days
n=3 participants at risk
Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 800 µg/Day for 14 Days
n=5 participants at risk
Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 14 Days
n=3 participants at risk
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 1600 µg/Day for 28 Days
n=3 participants at risk
Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 14 Days
n=6 participants at risk
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 3200 µg/Day for 28 Days
n=3 participants at risk
Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 14 Days
n=3 participants at risk
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
|
AMG 211 6400 µg/Day for 28 Days
n=10 participants at risk
Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
AMG 211 12,800 µg/Day for 28 Days
n=2 participants at risk
Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
2/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
3/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
4/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
4/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
2/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
4/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
2/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
3/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
2/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
5/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
2/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Feeling hot
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
30.0%
3/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
2/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cystitis
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Furuncle
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood potassium increased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Body temperature increased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
2/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
2/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
2/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
2/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
2/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depressed mood
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Stress
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough decreased
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
2/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
2/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
2/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Catheter removal
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Brachiocephalic vein thrombosis
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
2/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Product Issues
Device dislocation
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Product Issues
Device occlusion
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Disease progression
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER